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Data, safety & analytics

Grouped by study and the therapy under development, so every reported event is attributable to a drug. "Mechanism literature" links each event to published evidence connecting the drug class to the reported effect.

GAL-001: Adaptive Phase II in Refractory Melanoma

💊 NXC-101 (anti-PD-1 checkpoint inhibitor)

Pharmacovigilance — adverse events (3)

mild assessed on NXC-101 Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-24 (study day 19); relationship: not assessed

Auto-assessed as non-serious (mild). Included in aggregate safety reporting; no expedited report required.

severe serious under_review on NXC-101 Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-11 (study day 469); relationship: not assessed; serious criteria: hospitalization
mild assessed on NXC-101 Participant-reported via Luna chat: "I've had some nausea since yesterday evening". Solicited symptom report logged for the next visit review.

Auto-assessed as non-serious (mild). Included in aggregate safety reporting; no expedited report required.

Clinical data management — EDC queries (2)

weight_kg auto_resolved Missing value at Visit 3; source document shows 72 kg.

Auto-resolved: deterministic discrepancy in field "weight_kg" corrected against source rules. Flagged for audit trail.

conmed_dose needs_human Reported dose conflicts with pharmacy dispensing log; clinical interpretation needed (cross-check against deviation pattern "Subject received another investigational drug concurrently").

Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimers Disease.

💊 Xanomeline

Pharmacovigilance — adverse events (1191)

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-09 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-26 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-21 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 21.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-27 (study day 58.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-11-02 (study day 125.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BUNDLE BRANCH BLOCK LEFT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-10 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HIATUS HERNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HIATUS HERNIA — outcome: RECOVERED/RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-21 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-21 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PHARYNGOLARYNGEAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-03-21 (study day 80.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-03-31 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CELLULITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate LOCALISED INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-08 (study day -61.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-26 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-12-26 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-14 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2003; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EYE ALLERGY — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 84.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EYE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EYE SWELLING — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 84.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINARY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-06-01 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-26 (study day 38.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-22 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-26 (study day 38.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-03 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-16 (study day -4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-05-16 (study day -4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ACTINIC KERATOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-12 (study day 174.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CALCULUS URETHRAL — outcome: RECOVERED/RESOLVED; onset 2013-12-17 (study day 117.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-29 (study day -25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-02; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EPISTAXIS — outcome: RECOVERED/RESOLVED; onset 2014-01-03 (study day 134.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FLANK PAIN — outcome: RECOVERED/RESOLVED; onset 2013-12-15 (study day 115.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate LOWER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-12 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate LOWER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INCREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INCREASED APPETITE — outcome: RECOVERED/RESOLVED; onset 2013-10-13 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2002; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-15 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MICTURITION URGENCY — outcome: RECOVERED/RESOLVED; onset 2013-02-15 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate AGITATION — outcome: RECOVERED/RESOLVED; onset 2013-12-09 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-21 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-04 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-04 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-21 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2010-06; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2010-06; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate MUSCULAR WEAKNESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate MUSCULAR WEAKNESS — outcome: RECOVERED/RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL MUCOSA BIOPSY — outcome: RECOVERED/RESOLVED; onset 2012-08-03 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PNEUMONIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PNEUMONIA — outcome: RECOVERED/RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SECRETION DISCHARGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SECRETION DISCHARGE — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EYE LASER SURGERY — outcome: RECOVERED/RESOLVED; onset 2013-03-21 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-29 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-16 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-11 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPNOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-11 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INCONTINENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate JOINT DISLOCATION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-21 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN LACERATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-09 (study day 25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe SUDDEN DEATH — outcome: FATAL; onset 2013-01-14 (study day 61.0); relationship: NONE; serious criteria: death, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-20 (study day 10.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-01-20 (study day 10.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HORDEOLUM — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN ODOUR ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-20 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-13 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-02-13 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PAROSMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PAROSMIA — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SALIVARY HYPERSECRETION — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-02-23 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-22 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RHINORRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 166.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RHINORRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-07-09 (study day 166.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-26 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-03-22 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH ERYTHEMATOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PERSPIRATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: RECOVERED/RESOLVED; onset 2013-09-05 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-04 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EPISTAXIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-30 (study day 33.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FEELING ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-15 (study day 18.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild LIBIDO DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild LISTLESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-01 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-31 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PHARYNGOLARYNGEAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRODUCTIVE COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RESPIRATORY TRACT CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-23 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RHINITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-23 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild STOMACH DISCOMFORT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CYST — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-13 (study day -9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSPHONIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-11-03 (study day 166.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-09-12 (study day 114.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ONYCHOMYCOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-13 (study day -9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-22 (study day 21.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-25 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2012-12-25 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-05 (study day 6.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-16 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 137.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BACK PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-13 (study day 137.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 1986; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 1986; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-06-14 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PAIN — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 93.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHEST DISCOMFORT — outcome: RECOVERED/RESOLVED; onset 2013-06-24 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2013-07-17 (study day 164.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-06-24 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-03-18 (study day 7.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2014-03-18 (study day 7.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-03-16 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 168.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-02 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-21 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-21 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-21 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-01-21 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-10 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PARAESTHESIA — outcome: RECOVERED/RESOLVED; onset 2013-02-08 (study day 35.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-09-09 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NEUTROPHIL COUNT INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NEUTROPHIL COUNT INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RECTAL HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RECTAL HAEMORRHAGE — outcome: RECOVERED/RESOLVED; onset 2013-09-02 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINE ANALYSIS ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINE ANALYSIS ABNORMAL — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WHITE BLOOD CELL COUNT INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WHITE BLOOD CELL COUNT INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-03-04 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-03-05 (study day 4.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BENIGN PROSTATIC HYPERPLASIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BIOPSY PROSTATE — outcome: RECOVERED/RESOLVED; onset 2013-11-16 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERCHOLESTEROLAEMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2007; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-25 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHILLS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-09 (study day 38.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHILLS — outcome: RECOVERED/RESOLVED; onset 2012-10-09 (study day 38.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CATARACT OPERATION — outcome: RECOVERED/RESOLVED; onset 2013-04-25 (study day 44.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-28 (study day -13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-02-28 (study day -13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-17 (study day 127.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-07-17 (study day 127.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 76.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 25.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 25.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 74.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 74.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-18 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-22 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-22 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DECREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DECREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DISORIENTATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 18.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2001; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2001; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-11 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-08-11 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-28 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate GLAUCOMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 1992; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-13 (study day 183.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-09-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-15 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: RECOVERED/RESOLVED; onset 2014-03-15 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHEST DISCOMFORT — outcome: RECOVERED/RESOLVED; onset 2012-12-15 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2012-12-13 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2012-12-13 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate WEIGHT DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate WEIGHT DECREASED — outcome: RECOVERED/RESOLVED; onset 2012-12-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-30 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-25 (study day 44.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 40.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-17 (study day 22.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 10.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALAISE — outcome: RECOVERED/RESOLVED; onset 2013-09-05 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-09-22 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-14 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CYSTITIS — outcome: RECOVERED/RESOLVED; onset 2014-02-27 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-07-05 (study day 135.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN LACERATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-07-05 (study day 135.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CARDIAC DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-01 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2013-11-01 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-19 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-19 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PALPITATIONS — outcome: RECOVERED/RESOLVED; onset 2013-09-28 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VERTIGO — outcome: RECOVERED/RESOLVED; onset 2013-09-28 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WOLFF-PARKINSON-WHITE SYNDROME — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WOLFF-PARKINSON-WHITE SYNDROME — outcome: RECOVERED/RESOLVED; onset 2013-10-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ABDOMINAL DISCOMFORT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-26 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-11-17 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-12-15 (study day 53.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-11-17 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-24 (study day 62.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-09 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-22 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLOOD GLUCOSE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLOOD GLUCOSE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-03-30 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-23 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-28 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-12-28 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-27 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-27 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-23 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-23 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-08 (study day 39.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-08 (study day 39.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INFLUENZA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-27 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2012-09-27 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLOOD GLUCOSE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-30 (study day 42.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSPNOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-28 (study day 35.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-14 (study day -11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-08 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2013-11-08 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FLUTTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FLUTTER — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLISTER — outcome: RECOVERED/RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-06 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-12-06 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-11-09 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SEASONAL ALLERGY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-06 (study day -7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VIRAL INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-07-30 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 73.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-23 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BURNING SENSATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-03 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-18 (study day 41.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-01-18 (study day 41.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FLATULENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FLATULENCE — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild POLLAKIURIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild POLLAKIURIA — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-23 (study day -106.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PARKINSON'S DISEASE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-06 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe COMPLETED SUICIDE — outcome: FATAL; onset 2014-10-31 (study day 174.0); relationship: NONE; serious criteria: death

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-02 (study day 90.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERBILIRUBINAEMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-26 (study day 19.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-17 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPEPSIA — outcome: RECOVERED/RESOLVED; onset 2013-09-17 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 94.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-13 (study day 123.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-14 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate WOUND HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-09 (study day 69.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-04-08 (study day 30.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR HYPERTROPHY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-04-11 (study day 33.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2012-09-19 (study day 13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe COLON CANCER — outcome: RECOVERED/RESOLVED; onset 2013-01-21 (study day 137.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2011-12-05 (study day -277.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2011-12-05 (study day -277.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ANXIETY — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH ERYTHEMATOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-22 (study day -1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-05; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-05; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-07 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EXCORIATION — outcome: RECOVERED/RESOLVED; onset 2014-01-14 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate IRRITABILITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate IRRITABILITY — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-04 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-03-04 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-06-03 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 36.0); relationship: PROBABLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate EXCORIATION — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLOOD CREATINE PHOSPHOKINASE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-26 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLOOD CREATINE PHOSPHOKINASE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-11-26 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONJUNCTIVITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONJUNCTIVITIS — outcome: RECOVERED/RESOLVED; onset 2014-02-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild POSTNASAL DRIP — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-03 (study day 37.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild POSTNASAL DRIP — outcome: RECOVERED/RESOLVED; onset 2013-12-03 (study day 37.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS ARRHYTHMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS ARRHYTHMIA — outcome: RECOVERED/RESOLVED; onset 2013-11-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-12-31 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe STUPOR — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VISION BLURRED — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-02-26 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-05-23 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-06-09 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-23 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-06-23 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 106.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 118.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE IRREGULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE IRREGULAR — outcome: RECOVERED/RESOLVED; onset 2013-01-19 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE IRREGULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 146.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE IRREGULAR — outcome: RECOVERED/RESOLVED; onset 2013-03-16 (study day 146.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-25 (study day 18.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-03-22 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ALCOHOL USE — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CYSTITIS — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FLANK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-19 (study day -10.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2014-03-01 (study day 63.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2013-02-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONJUNCTIVITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONJUNCTIVITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-07 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEART RATE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-02-27 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-02-11 (study day 6.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-07 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-03-07 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HOT FLUSH — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 42.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe MUSCLE SPASMS — outcome: RECOVERED/RESOLVED; onset 2013-02-18 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-21 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 162.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-12 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONSTIPATION — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 162.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-23 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-04 (study day 83.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-09-04 (study day 83.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-04 (study day 113.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-10-04 (study day 113.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL HYPERTROPHY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-27 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIAL HYPERTROPHY — outcome: RECOVERED/RESOLVED; onset 2013-06-27 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PAIN IN EXTREMITY — outcome: RECOVERED/RESOLVED; onset 2013-12-07 (study day 177.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 68.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 68.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-15 (study day 177.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-29 (study day 160.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-12 (study day 37.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2012-12-18 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-02 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE SWELLING — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-01 (study day 119.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-08-18 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-18 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-08-28 (study day 56.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-16 (study day 173.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-16 (study day 173.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE WARMTH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE WARMTH — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EPISTAXIS — outcome: RECOVERED/RESOLVED; onset 2013-11-22 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-16 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-08-16 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2012-08-30 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2013-01-03 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-15 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-01-03 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-17 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MUSCLE SPASMS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-24 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MUSCLE SPASMS — outcome: RECOVERED/RESOLVED; onset 2013-01-24 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-09 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-01-09 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-15 (study day 142.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PHARYNGEAL ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PHARYNGEAL ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-19 (study day 177.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-12 (study day 170.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-01 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-07 (study day 80.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-08 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-02 (study day 113.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ACROCHORDON EXCISION — outcome: RECOVERED/RESOLVED; onset 2014-03-23 (study day 150.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-06 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-11-06 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-03-26 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 65.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-17 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-08-17 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-27 (study day 24.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-01 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-04-01 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-05-17 (study day 75.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DISCHARGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-28 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-05-31 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN LESION EXCISION — outcome: RECOVERED/RESOLVED; onset 2013-06-28 (study day 45.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BENIGN PROSTATIC HYPERPLASIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe BENIGN PROSTATIC HYPERPLASIA — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLOOD URINE PRESENT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-14 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CYSTOSCOPY — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DEHYDRATION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild LOCALISED INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild LOCALISED INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ORTHOSTATIC HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ORTHOSTATIC HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEMIANOPIA HOMONYMOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-14 (study day 22.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIABETES MELLITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-04 (study day 91.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-05-04 (study day 91.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DRUG ERUPTION — outcome: RECOVERED/RESOLVED; onset 2014-05-20 (study day 107.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ALLERGIC GRANULOMATOUS ANGIITIS — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-28 (study day 40.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BIOPSY — outcome: RECOVERED/RESOLVED; onset 2013-06-26 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-01 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-07-01 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FEELING COLD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 80.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NIGHTMARE — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH MACULO-PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day -9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH MACULO-PAPULAR — outcome: RECOVERED/RESOLVED; onset 2013-06-10 (study day -9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH MACULO-PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-20 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH PAPULAR — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-19 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-17 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-10-19 (study day 183.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE BLEEDING — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 64.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-12 (study day 99.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 47.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 47.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-25 (study day 11.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2013-08-25 (study day 11.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLOOD ALKALINE PHOSPHATASE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2011-11; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate serious reported on Xanomeline Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-07 (study day 5.0); relationship: POSSIBLE; serious criteria: life-threatening
mild assessed on Xanomeline Mild TRANSIENT ISCHAEMIC ATTACK — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-16 (study day 3.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2014-01-16 (study day 3.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-18 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-04-16 (study day 66.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FACIAL BONES FRACTURE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NEPHROLITHIASIS — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 67.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-18 (study day 98.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-29 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-06-29 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 67.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHEST PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-10-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HAEMOPTYSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HAEMOPTYSIS — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RALES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-23 (study day 85.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RALES — outcome: RECOVERED/RESOLVED; onset 2014-05-23 (study day 85.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-03 (study day 62.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-08-03 (study day 62.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-22 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-07-22 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN EXFOLIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day 72.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN EXFOLIATION — outcome: RECOVERED/RESOLVED; onset 2013-08-13 (study day 72.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-06-22 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE INDURATION — outcome: RECOVERED/RESOLVED; onset 2013-01-21 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-23 (study day 23.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-31 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-02-08 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-02-09 (study day 40.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-04 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-01-04 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2013-01-02 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe GASTROINTESTINAL HAEMORRHAGE — outcome: RECOVERED/RESOLVED; onset 2013-02-05 (study day 151.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-01-22 (study day 137.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-06 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 57.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-12-12 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1977; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1977; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-27 (study day 41.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe MYOCARDIAL INFARCTION — outcome: FATAL; onset 2013-08-02 (study day 12.0); relationship: POSSIBLE; serious criteria: hospitalization, death, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-13 (study day 34.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VERTIGO — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-04 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2012-10-04 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2012-10-04 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2012-10-19 (study day 18.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2012-10-14 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SYNCOPE VASOVAGAL — outcome: RECOVERED/RESOLVED; onset 2012-10-19 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COMPLEX PARTIAL SEIZURES — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FALL — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN LACERATION — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 111.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIOVENTRICULAR BLOCK FIRST DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-10 (study day 115.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-10 (study day 115.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-23 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-29 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2012-11-22 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-13 (study day 110.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-11 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 53.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 118.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-09-29 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 119.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 121.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-09-29 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 119.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 121.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-07-03 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-21 (study day 70.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-21 (study day 70.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CARDIAC FAILURE CONGESTIVE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 57.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPNOEA — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPONATRAEMIA — outcome: RECOVERED/RESOLVED; onset 2012-11-22 (study day 57.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BURNING SENSATION — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-07 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SOMNOLENCE — outcome: RECOVERED/RESOLVED; onset 2013-01-13 (study day 21.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-03-02 (study day 69.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-13 (study day 61.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-10 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-10 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-31 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-02-26 (study day -1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-14 (study day 77.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-05-14 (study day 77.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-30 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-14 (study day 96.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DESQUAMATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-24 (study day 130.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-22 (study day 97.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-22 (study day 97.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DELUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-26 (study day 155.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe HIP FRACTURE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-25 (study day 64.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-12-25 (study day 64.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PSYCHOMOTOR HYPERACTIVITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-26 (study day 155.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-18 (study day 113.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ATRIOVENTRICULAR BLOCK FIRST DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-26 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-18 (study day 113.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-18 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SUPRAVENTRICULAR TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SUPRAVENTRICULAR TACHYCARDIA — outcome: RECOVERED/RESOLVED; onset 2012-11-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-24 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-31 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-01-31 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE URTICARIA — outcome: RECOVERED/RESOLVED; onset 2013-04-29 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-27 (study day 25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-04 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-08-04 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild GLOSSITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-29 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-18 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CERUMEN IMPACTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-01 (study day 60.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONJUNCTIVAL HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 58.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PARAESTHESIA ORAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-11 (study day 9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-27 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH PRURITIC — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-29 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-04-29 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate TINNITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2007-10; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-28 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-05-28 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-05 (study day 10.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-23 (study day -188.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-23 (study day -188.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CATARACT OPERATION — outcome: RECOVERED/RESOLVED; onset 2014-03-08 (study day 175.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-14 (study day 107.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-30 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DELIRIUM — outcome: RECOVERED/RESOLVED; onset 2013-07-01 (study day 32.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH PRURITIC — outcome: RECOVERED/RESOLVED; onset 2013-06-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CERVICITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CERVICITIS — outcome: RECOVERED/RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSPEPSIA — outcome: RECOVERED/RESOLVED; onset 2013-08-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-12 (study day 35.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSURIA — outcome: RECOVERED/RESOLVED; onset 2013-08-19 (study day 11.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate GASTROENTERITIS VIRAL — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 63.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild GASTROOESOPHAGEAL REFLUX DISEASE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PELVIC PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PELVIC PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINARY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-28 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-08-28 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VAGINAL MYCOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VAGINAL MYCOSIS — outcome: RECOVERED/RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ABDOMINAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ABDOMINAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-02 (study day 7.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 158.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-30 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-10-30 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-02 (study day 7.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 82.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-10 (study day 165.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-10 (study day 165.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-01 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-01 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-19 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-03-19 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-27 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-03-27 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BRONCHITIS — outcome: RECOVERED/RESOLVED; onset 2014-07-18 (study day 93.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BUNDLE BRANCH BLOCK RIGHT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BUNDLE BRANCH BLOCK RIGHT — outcome: RECOVERED/RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-12 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-08-12 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-13 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-05-13 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-17 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DYSURIA — outcome: RECOVERED/RESOLVED; onset 2013-07-25 (study day 91.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-14 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-08 (study day 95.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 83.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BACK PAIN — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 83.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2014-01-22 (study day 50.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-12-14 (study day 11.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-12-13 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-11 (study day 39.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2014-01-22 (study day 50.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-27 (study day 175.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-04 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR PAIN — outcome: RECOVERED/RESOLVED; onset 2013-04-04 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 111.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 111.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 93.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 93.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 33.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-03-30 (study day 33.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DERMATITIS CONTACT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DERMATITIS CONTACT — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-13 (study day 77.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NEPHROLITHIASIS — outcome: RECOVERED/RESOLVED; onset 2013-01-10 (study day 54.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-03-18 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE REACTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-21 (study day 70.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-14 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-03-14 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-22 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONFUSIONAL STATE — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PALPITATIONS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-07-13 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EMPHYSEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-16 (study day 161.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-20 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2012-08-20 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-07-16 (study day 106.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-08-15 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-31 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: RECOVERED/RESOLVED; onset 2014-04-18 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-17 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-17 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 172.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-01 (study day 54.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 366.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate LETHARGY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-31 (study day 84.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-04 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RESTLESSNESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-28 (study day 81.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate RESTLESSNESS — outcome: RECOVERED/RESOLVED; onset 2013-07-28 (study day 81.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-07-31 (study day 54.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ATRIAL FLUTTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BUNDLE BRANCH BLOCK RIGHT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLISTER — outcome: RECOVERED/RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-17 (study day 151.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe BLISTER — outcome: RECOVERED/RESOLVED; onset 2014-08-17 (study day 151.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-15 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALIGNANT FIBROUS HISTIOCYTOMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-19 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MALIGNANT FIBROUS HISTIOCYTOMA — outcome: RECOVERED/RESOLVED; onset 2013-02-19 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-15 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-17 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-03 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERSENSITIVITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-10 (study day 154.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERSENSITIVITY — outcome: RECOVERED/RESOLVED; onset 2013-03-10 (study day 154.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-17 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-17 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-24 (study day -9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DELUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-24 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HALLUCINATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-24 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe PROSTATE CANCER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-07 (study day 122.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-05 (study day 89.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BLOOD CHOLESTEROL INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-20 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-08 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BLISTER — outcome: RECOVERED/RESOLVED; onset 2013-06-08 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-07-22 (study day 70.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-05-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ULCER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-02 (study day 81.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COGNITIVE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-14 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 145.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-09-26 (study day 145.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild URTICARIA — outcome: RECOVERED/RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VISION BLURRED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VISION BLURRED — outcome: RECOVERED/RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-11 (study day 110.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CHEST PAIN — outcome: RECOVERED/RESOLVED; onset 2014-04-05 (study day 111.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-14 (study day 89.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-01 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-21 (study day 128.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-13 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-13 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ENURESIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild IRRITABILITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RHINORRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RHINORRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-08 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-21 (study day 98.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WOUND — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-03 (study day 141.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild WOUND — outcome: RECOVERED/RESOLVED; onset 2014-06-03 (study day 141.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-20 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2014-02-15 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INCREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-29 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INCREASED APPETITE — outcome: RECOVERED/RESOLVED; onset 2014-01-29 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-22 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS GENERALISED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-04 (study day 37.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-15 (study day 20.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 82.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 86.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-03 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-03 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe RASH — outcome: RECOVERED/RESOLVED; onset 2013-04-25 (study day 94.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ALOPECIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 28.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-19 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-01 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: RECOVERED/RESOLVED; onset 2014-02-01 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-02-01 (study day 22.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-02-28 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-02-28 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PERSPIRATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-11 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PERSPIRATION — outcome: RECOVERED/RESOLVED; onset 2013-06-11 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1994-04; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-10 (study day 102.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-07-22 (study day 83.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day 68.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-15 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ANXIETY — outcome: RECOVERED/RESOLVED; onset 2013-09-15 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PAIN — outcome: RECOVERED/RESOLVED; onset 2014-01-13 (study day 135.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-28 (study day 150.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-07 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-10-07 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-06 (study day 36.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-10-06 (study day 36.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-19 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-18 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate INFLAMMATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-30 (study day 24.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-07-16 (study day 10.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe SYNCOPE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-30 (study day 24.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-14 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-04-14 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-06 (study day 140.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-13 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 18.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-11-16 (study day 182.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-03 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: RECOVERED/RESOLVED; onset 2013-06-03 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-03-15 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 149.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-02-16 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-10 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-05-10 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FOOD CRAVING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 142.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-31 (study day 194.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-16 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BODY TEMPERATURE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-10-07 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild HYPERTENSION — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Xanomeline Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 27.0); relationship: PROBABLE; serious criteria: hospitalization
moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate BALANCE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BALANCE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BALANCE DISORDER — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild CONTUSION — outcome: RECOVERED/RESOLVED; onset 2013-10-15 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild COORDINATION ABNORMAL — outcome: RECOVERED/RESOLVED; onset 2013-11-15 (study day 56.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 19.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DISCOLOURATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-25 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild ARTHRALGIA — outcome: RECOVERED/RESOLVED; onset 2013-07-25 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DYSPHAGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 114.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate FOOD CRAVING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 114.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-03 (study day 56.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: RECOVERED/RESOLVED; onset 2013-09-03 (study day 56.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-23 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-03-23 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-04-02 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-04-27 (study day 59.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 74.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-16 (study day 78.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-20 (study day 82.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE REACTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-23 (study day 116.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE REACTION — outcome: RECOVERED/RESOLVED; onset 2013-06-23 (study day 116.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-17 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DERMATITIS ATOPIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 1982; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-15 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HYPERTENSION — outcome: RECOVERED/RESOLVED; onset 2013-08-15 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN ULCER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-08 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SKIN ULCER — outcome: RECOVERED/RESOLVED; onset 2013-03-08 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-25 (study day 87.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-24 (study day 29.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-24 (study day 29.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild FATIGUE — outcome: RECOVERED/RESOLVED; onset 2013-05-09 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate HALLUCINATION, VISUAL — outcome: RECOVERED/RESOLVED; onset 2013-06-02 (study day 38.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-05-09 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Xanomeline Severe PARTIAL SEIZURES WITH SECONDARY GENERALISATION — outcome: RECOVERED/RESOLVED; onset 2013-06-02 (study day 38.0); relationship: NONE; serious criteria: hospitalization
mild assessed on Xanomeline Mild AMNESIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-01 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild AMNESIA — outcome: RECOVERED/RESOLVED; onset 2013-01-01 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-01-27 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-29 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-27 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-27 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Xanomeline Mild BACK PAIN — outcome: RECOVERED/RESOLVED; onset 2012-12-18 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DECREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate DECREASED APPETITE — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate LETHARGY — outcome: RECOVERED/RESOLVED; onset 2013-01-05 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2012-12-26 (study day 10.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-01-03 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-01-16 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Xanomeline Severe NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-01-21 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Xanomeline Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Clinical data management — EDC queries (0)

No data queries.

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

💊 Torivumab (programmed death receptor-1 blocking antibody) + platinum-based chemotherapy

Pharmacovigilance — adverse events (2840)

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-11 (study day 12); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-11 (study day 12); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-04-25 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-08 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-24 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-25 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-26 (study day 21); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-10 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 53); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-03 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-20 (study day 160); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-13 (study day 183); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 474); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 475); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-15 (study day 489); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-05 (study day 601); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-18 (study day 97); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-08-23 (study day 102); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 250); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-02-07 (study day 270); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 454); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-03 (study day 600); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-11 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-01 (study day 160); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 176); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 280); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: UNKNOWN; onset 2023-04-04 (study day 314); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-07-21 (study day 422); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 458); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-23 (study day 547); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-16 (study day 601); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 125); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 129); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-19 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-22 (study day 209); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-23 (study day 241); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-06-19 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 39); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-19 (study day 44); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-24 (study day 49); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-07-13 (study day 15); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: UNKNOWN; onset 2022-07-15 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 57); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-02 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-09-02 (study day 66); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 81); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 138); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-30 (study day 57); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-04 (study day 427); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 439); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-11-03 (study day 487); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 508); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-08 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-02 (study day 124); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 141); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-01 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-12-06 (study day 115); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-05 (study day 510); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 599); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 601); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 385); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-07 (study day 472); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-02-28 (study day 555); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-10-29 (study day 43); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-05 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 245); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-22 (study day 340); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-03 (study day 443); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 456); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 4); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 4); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-05 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 96); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-05 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 216); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 51); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 72); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 77); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 313); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-29 (study day 345); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-15 (study day 423); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-11 (study day 540); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 603); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 84); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-23 (study day 144); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-01-02 (study day 368); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-28 (study day 454); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-05-12 (study day 499); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-28 (study day 546); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-03 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-12 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-26 (study day 100); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-12 (study day 116); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 135); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-19 (study day 246); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 38); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 107); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 148); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-03 (study day 193); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 176); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 191); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 293); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-08 (study day 305); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: UNKNOWN; onset 2024-03-24 (study day 381); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-18 (study day 161); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-09 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-27 (study day 105); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-13 (study day 153); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 181); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-01-13 (study day 275); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 119); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-07 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-25 (study day 336); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 338); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-06-10 (study day 413); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: UNKNOWN; onset 2024-06-29 (study day 432); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-04 (study day 5); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-04 (study day 5); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-05 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 18); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 18); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 19); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 20); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-27 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-01 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-03 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-25 (study day 39); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 51); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-30 (study day 74); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-08-04 (study day 79); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 43); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: UNKNOWN; onset 2023-08-11 (study day 75); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 81); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 317); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-10 (study day 409); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-10-06 (study day 497); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-11-18 (study day 540); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 25); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-09 (study day 293); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-07-24 (study day 338); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-18 (study day 394); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 153); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-05-31 (study day 280); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-08-30 (study day 371); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-11-21 (study day 454); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-23 (study day 16); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 94); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-04 (study day 150); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-12 (study day 235); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 262); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 389); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 522); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-07 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-26 (study day 57); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 119); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-10 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-15 (study day 138); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 266); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 324); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 345); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-30 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-11 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 279); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-14 (study day 398); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-22 (study day 436); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 589); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-04-24 (study day 713); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-27 (study day 838); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-06-02 (study day 10); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 30); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 30); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 36); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2022-07-07 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-21 (study day 59); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-21 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-13 (study day 113); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 116); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 28); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-18 (study day 48); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: UNKNOWN; onset 2022-08-10 (study day 71); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 85); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 126); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-31 (study day 153); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-12 (study day 165); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-06-03 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 5); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-10 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 195); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 210); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 230); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 294); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-07 (study day 371); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-26 (study day 227); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 238); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-09 (study day 516); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-12-17 (study day 96); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-12-26 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 117); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 169); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 301); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 65); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 160); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-20 (study day 172); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 413); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 435); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 545); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-05 (study day 584); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-15 (study day 4); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 100); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 164); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 285); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 307); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 41); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-10 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-12 (study day 139); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-24 (study day 29); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-26 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 167); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-25 (study day 181); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 237); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 257); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 299); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-15 (study day 385); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 132); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 172); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 183); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 266); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-22 (study day 325); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-23 (study day 387); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-07-01 (study day 608); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-29 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 72); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 111); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 121); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-12 (study day 214); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 320); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-29 (study day 165); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 290); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 329); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 330); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-27 (study day 74); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 83); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 171); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-01 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 32); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 125); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 184); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-17 (study day 396); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-20 (study day 399); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-11 (study day 421); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-03 (study day 164); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 182); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 299); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 335); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-12 (study day 478); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-02 (study day 498); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-06-10 (study day 537); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 539); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-03-26 (study day 94); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-23 (study day 152); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 187); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-17 (study day 451); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-21 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 77); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 232); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-09 (study day 254); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-23 (study day 268); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: UNKNOWN; onset 2023-07-17 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 154); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-30 (study day 276); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-01-12 (study day 319); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-21 (study day 328); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-01 (study day 339); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-25 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-10 (study day 32); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 58); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-21 (study day 104); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 12); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-25 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-30 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-02 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 21); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 43); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 47); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 63); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-08 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-30 (study day 11); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-14 (study day 26); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 159); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-26 (study day 160); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 186); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-29 (study day 255); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 150); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-22 (study day 308); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-09-02 (study day 411); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-20 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-01-15 (study day 169); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-24 (study day 178); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-04-06 (study day 251); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-04-21 (study day 266); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-29 (study day 274); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-02 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 58); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 208); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-04-19 (study day 263); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-24 (study day 298); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-06-13 (study day 318); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-11 (study day 469); relationship: not assessed; serious criteria: hospitalization
severe serious assessed on Torivumab Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 106); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-28 (study day 174); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 237); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-06-04 (study day 302); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-03-16 (study day 10); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-03-30 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-04-29 (study day 54); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-07-18 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-23 (study day 201); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2022-06-13 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-03 (study day 295); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 296); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-30 (study day 381); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 96); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 152); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 349); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-12 (study day 377); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-24 (study day 450); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-28 (study day 485); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-07-05 (study day 797); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-02 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-06-08 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-06-18 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-06 (study day 57); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-08-10 (study day 92); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-12 (study day 94); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-16 (study day 98); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: UNKNOWN; onset 2022-08-24 (study day 106); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 132); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-25 (study day 10); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-11 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-15 (study day 92); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-18 (study day 95); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-31 (study day 108); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-06 (study day 114); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 129); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-24 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-09 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-16 (study day 363); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-02 (study day 441); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 453); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-12 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-09-01 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-10-10 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-19 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-10-30 (study day 101); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-11-03 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-06 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 311); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 357); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-23 (study day 81); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: UNKNOWN; onset 2022-11-06 (study day 95); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 107); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-11-23 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 198); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-28 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 164); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 426); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 434); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-29 (study day 536); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-02-02 (study day 540); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-22 (study day 560); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-11-07 (study day 57); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-20 (study day 131); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-31 (study day 201); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 224); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-02 (study day 386); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 416); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 416); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 554); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 150); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-27 (study day 253); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-24 (study day 311); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-07 (study day 15); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-09 (study day 48); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 87); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-27 (study day 199); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 213); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-16 (study day 218); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 311); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 326); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 133); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 240); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-04 (study day 601); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-11-08 (study day 728); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-11-14 (study day 734); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-12-27 (study day 777); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 15); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-12 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-31 (study day 123); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 128); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 140); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-08 (study day 8); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-15 (study day 350); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-11 (study day 376); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-25 (study day 512); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 95); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 126); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-08 (study day 189); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 353); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 123); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 236); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-06 (study day 350); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-13 (study day 388); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 400); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-15 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-15 (study day 201); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 285); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-04 (study day 313); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2024-01-19 (study day 389); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-18 (study day 509); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-04-03 (study day 40); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-04-24 (study day 61); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 145); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 159); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-26 (study day 277); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-03 (study day 315); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-11 (study day 354); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 406); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 507); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-09-18 (study day 574); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-04 (study day 40); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 42); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 121); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 130); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 131); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 56); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-02 (study day 147); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 158); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 168); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-30 (study day 206); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 231); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: UNKNOWN; onset 2023-10-30 (study day 236); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-30 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 87); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-22 (study day 167); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 233); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-05-08 (study day 396); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 17); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-19 (study day 92); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-28 (study day 223); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-04 (study day 230); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-01 (study day 258); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-18 (study day 275); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-10 (study day 296); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 320); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-05-22 (study day 369); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: UNKNOWN; onset 2023-07-07 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 114); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-13 (study day 123); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 160); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 187); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-02-05 (study day 238); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 292); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 10); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-24 (study day 79); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 173); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-16 (study day 224); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-19 (study day 256); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-09-19 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 79); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-28 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-29 (study day 221); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-08 (study day 229); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 239); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-22 (study day 274); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 325); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-06-21 (study day 334); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-29 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Vomiting — outcome: UNKNOWN; onset 2023-10-30 (study day 95); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 148); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-29 (study day 186); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-04 (study day 252); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-15 (study day 171); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 118); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: UNKNOWN; onset 2024-03-02 (study day 181); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-12 (study day 313); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-09-06 (study day 369); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-04-23 (study day 32); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 39); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 128); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-31 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-09 (study day 3); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 6); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: UNKNOWN; onset 2022-05-09 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-06-09 (study day 64); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-13 (study day 129); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-30 (study day 34); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-30 (study day 34); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-17 (study day 235); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: UNKNOWN; onset 2023-01-18 (study day 267); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-28 (study day 367); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-06-14 (study day 9); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 126); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-12 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 468); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-21 (study day 595); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 612); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-03-21 (study day 655); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-06-13 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-06-15 (study day 5); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-17 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-23 (study day 13); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-07-18 (study day 38); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 48); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-30 (study day 81); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-08 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-07-19 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 34); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-25 (study day 185); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 342); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-12 (study day 354); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 371); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 397); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-25 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-08-05 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-08-12 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 63); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-30 (study day 90); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-12 (study day 102); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-13 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-25 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-08 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 54); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-18 (study day 71); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-19 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 56); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 70); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-09 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 114); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-08 (study day 225); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 232); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2022-10-11 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 103); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 129); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 132); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-26 (study day 314); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 343); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 399); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-06 (study day 417); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: UNKNOWN; onset 2023-01-04 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 267); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-01 (study day 279); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-17 (study day 22); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-28 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-30 (study day 35); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-11-28 (study day 64); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 122); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-16 (study day 172); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-12 (study day 229); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-18 (study day 388); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-11-07 (study day 408); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 3); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 7); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 315); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 404); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-27 (study day 634); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-09-25 (study day 694); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 260); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-07 (study day 284); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-06-11 (study day 562); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 52); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 93); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2023-04-15 (study day 132); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-20 (study day 137); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-05 (study day 213); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-05 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-16 (study day 85); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-21 (study day 90); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 26); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-23 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-27 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-13 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 87); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-01 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 92); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: UNKNOWN; onset 2024-06-15 (study day 485); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-05 (study day 505); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 45); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-11 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-12 (study day 390); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-21 (study day 10); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 42); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 61); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-02 (study day 479); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-16 (study day 524); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-09-02 (study day 541); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-10 (study day 28); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 32); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-09 (study day 149); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 217); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-11-30 (study day 262); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 271); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-05-24 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 113); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-28 (study day 208); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-19 (study day 260); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-02-10 (study day 313); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-07-03 (study day 457); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 41); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 123); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 178); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 291); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-01 (study day 375); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-05-04 (study day 378); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-12-05 (study day 593); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2025-01-14 (study day 633); relationship: not assessed; serious criteria: hospitalization
mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2025-01-16 (study day 635); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 98); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 116); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2024-04-18 (study day 355); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-03 (study day 493); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-05 (study day 56); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 95); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 258); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-24 (study day 441); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-06 (study day 454); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-12 (study day 460); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-08-18 (study day 466); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 21); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 21); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-06 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-29 (study day 80); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-12 (study day 94); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 96); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-08 (study day 238); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-15 (study day 397); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-07-17 (study day 429); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-12 (study day 516); relationship: not assessed; serious criteria: hospitalization
mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-11-29 (study day 564); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2025-01-01 (study day 597); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-15 (study day 20); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 38); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-06 (study day 41); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 42); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-28 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 71); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 86); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 82); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-04 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-17 (study day 226); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-26 (study day 35); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 126); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-04-06 (study day 198); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-04 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-04-07 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: UNKNOWN; onset 2022-08-17 (study day 171); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-29 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 467); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 539); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 551); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 552); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-05-05 (study day 49); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-06 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-11 (study day 55); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 72); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-05 (study day 80); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 103); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-03 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-04-09 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-04 (study day 70); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 221); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-25 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 305); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-24 (study day 335); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-06-03 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-06-21 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 52); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-30 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-06 (study day 66); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-09 (study day 69); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 33); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-05 (study day 62); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 289); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 403); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-08 (study day 522); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 541); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 569); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 592); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-27 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-29 (study day 212); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 291); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-30 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-01-23 (study day 211); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-27 (study day 427); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-30 (study day 522); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 40); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2022-09-21 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-20 (study day 370); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: UNKNOWN; onset 2023-08-07 (study day 388); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 402); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-26 (study day 620); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-05 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 111); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 120); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 126); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-23 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-06 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 121); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-12 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 198); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 202); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-17 (study day 209); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-13 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 11); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-25 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-13 (study day 37); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-09 (study day 64); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 54); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 273); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-09 (study day 302); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: UNKNOWN; onset 2022-12-18 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 216); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 225); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 239); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 280); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 400); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2023-06-09 (study day 173); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 188); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 198); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 251); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-11-23 (study day 340); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 242); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 409); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-04-13 (study day 476); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 7); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 21); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-31 (study day 78); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 160); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-20 (study day 21); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 30); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 40); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 78); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 93); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 10); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-04 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 88); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-26 (study day 160); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-01 (study day 227); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-13 (study day 270); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 284); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 37); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-12 (study day 62); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-05 (study day 116); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 274); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-29 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-21 (study day 131); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-29 (study day 186); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 209); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-05 (study day 405); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-05-29 (study day 429); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-12 (study day 42); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-11-06 (study day 220); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 80); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-07-14 (study day 102); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-11-03 (study day 214); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-11 (study day 374); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-10 (study day 587); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-12 (study day 5); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-27 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 161); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 234); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-24 (study day 383); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-07 (study day 427); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-06-20 (study day 440); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-31 (study day 481); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-09-02 (study day 514); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 85); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-03 (study day 290); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 323); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 352); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-08-05 (study day 474); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-10-15 (study day 545); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-24 (study day 23); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: UNKNOWN; onset 2023-06-08 (study day 38); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 127); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-20 (study day 142); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-02 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 179); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 199); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 208); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2023-06-25 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 109); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 142); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 169); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 186); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-02-21 (study day 282); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-25 (study day 286); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 320); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 159); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-06 (study day 270); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-03-25 (study day 289); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 25); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 30); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-27 (study day 41); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-29 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-21 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 5); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-25 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-06 (study day 78); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 91); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-20 (study day 123); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-08 (study day 263); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-20 (study day 275); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-22 (study day 277); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 409); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-19 (study day 504); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 562); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 588); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 593); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 647); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-03 (study day 703); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 769); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-03-31 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-05-01 (study day 34); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-07 (study day 40); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-11 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-22 (study day 55); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 60); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-15 (study day 79); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-05-16 (study day 12); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 14); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-19 (study day 15); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-01 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2022-07-01 (study day 47); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-26 (study day 72); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-08-21 (study day 98); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 135); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 173); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 211); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 227); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-26 (study day 69); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 98); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-11 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 205); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-14 (study day 210); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-30 (study day 377); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-12 (study day 451); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-29 (study day 529); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-31 (study day 68); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 94); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-10 (study day 109); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-10 (study day 109); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 18); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-11-01 (study day 109); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-01 (study day 170); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-06-05 (study day 691); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-11-03 (study day 842); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-08 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 61); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-06 (study day 3); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-11 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-20 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-06 (study day 95); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-18 (study day 4); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-21 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-09 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 367); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 400); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-14 (study day 426); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-10-25 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-11-01 (study day 22); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 40); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-13 (study day 313); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 316); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-18 (study day 440); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-04 (study day 457); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-10 (study day 30); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-20 (study day 40); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-15 (study day 66); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-06-25 (study day 227); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-19 (study day 313); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 17); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 32); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-15 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 67); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 6); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-23 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 13); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 40); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-11 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2023-02-12 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 53); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-24 (study day 107); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-08 (study day 152); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 173); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-29 (study day 265); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-20 (study day 347); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-13 (study day 371); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 384); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 387); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-04-19 (study day 407); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-25 (study day 474); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-28 (study day 538); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: UNKNOWN; onset 2024-09-28 (study day 569); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-29 (study day 40); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 91); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 106); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-07 (study day 262); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-19 (study day 336); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-03-11 (study day 357); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: UNKNOWN; onset 2024-06-08 (study day 446); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-02 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 59); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 75); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-19 (study day 95); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: UNKNOWN; onset 2023-06-28 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 88); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 143); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-12 (study day 151); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 110); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-10 (study day 336); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-30 (study day 448); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-31 (study day 61); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-20 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 149); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 162); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-15 (study day 289); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-22 (study day 326); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-07-10 (study day 375); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: UNKNOWN; onset 2024-07-12 (study day 377); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-13 (study day 98); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-01-24 (study day 201); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-05-16 (study day 314); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-05-21 (study day 319); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-01 (study day 330); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-19 (study day 348); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-06-22 (study day 351); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-07-24 (study day 383); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-08-04 (study day 394); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-02 (study day 24); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-07 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-06-21 (study day 348); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 2); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 22); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 22); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 73); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 90); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-19 (study day 122); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-29 (study day 132); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 18); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 20); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-21 (study day 24); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 65); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 52); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 54); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-30 (study day 60); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 107); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 212); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-05-05 (study day 248); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 188); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-06-06 (study day 271); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-06-30 (study day 295); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2024-10-29 (study day 416); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 111); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-23 (study day 204); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-04 (study day 703); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-05-14 (study day 803); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2024-08-09 (study day 890); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-06 (study day 101); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-09 (study day 104); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-28 (study day 215); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-20 (study day 268); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 356); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-01 (study day 889); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 3); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-14 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-26 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-04-26 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-29 (study day 20); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-01 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-04 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-06 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-09 (study day 30); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-06-23 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-07-04 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-04 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-10 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-12 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-15 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 60); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-07 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-11 (study day 67); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-07-13 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Dyspnoea — outcome: UNKNOWN; onset 2022-09-18 (study day 95); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-28 (study day 105); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-10-23 (study day 130); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 148); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-11-11 (study day 149); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2022-07-26 (study day 14); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-26 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-07-31 (study day 19); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-31 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-11-25 (study day 115); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-16 (study day 167); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 168); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-20 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 296); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 539); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-09-15 (study day 775); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-26 (study day 816); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-25 (study day 65); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-25 (study day 65); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 173); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-31 (study day 222); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 263); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-11-03 (study day 439); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 461); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-24 (study day 490); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-11-15 (study day 73); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 149); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-28 (study day 237); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 299); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 475); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-23 (study day 476); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-01-17 (study day 501); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-05 (study day 549); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-17 (study day 40); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-11-27 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-12 (study day 127); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-02-24 (study day 170); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-25 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-29 (study day 30); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 42); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-08 (study day 132); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 143); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-30 (study day 151); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-20 (study day 172); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 16); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 32); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 100); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 50); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 57); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 72); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 96); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 96); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 159); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 175); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 212); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-30 (study day 14); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 298); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-13 (study day 301); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-11-10 (study day 329); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-02-12 (study day 423); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: UNKNOWN; onset 2024-02-17 (study day 428); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 455); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 32); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-05 (study day 66); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-06-15 (study day 168); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: UNKNOWN; onset 2023-02-06 (study day 12); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 23); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 70); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-04-12 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-05 (study day 100); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 104); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-22 (study day 117); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 124); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 128); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 163); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-05-16 (study day 91); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-24 (study day 222); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 306); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 416); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-23 (study day 434); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-07-15 (study day 517); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-08-20 (study day 553); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-14 (study day 608); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 222); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-16 (study day 350); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-04-19 (study day 413); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-05-08 (study day 432); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-27 (study day 543); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-10-17 (study day 594); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 52); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-21 (study day 374); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-06-30 (study day 444); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 2); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-12-18 (study day 245); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-10-13 (study day 545); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-12-17 (study day 610); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2025-01-01 (study day 625); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 175); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-18 (study day 179); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 213); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-07-12 (study day 447); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-07-20 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-09-22 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 190); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 212); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 233); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-04 (study day 329); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 20); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 98); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 104); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 139); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-01 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 222); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: UNKNOWN; onset 2024-04-08 (study day 266); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-05-01 (study day 289); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-18 (study day 337); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-11 (study day 360); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 54); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 58); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-28 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 124); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 130); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-18 (study day 153); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-14 (study day 171); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-27 (study day 184); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-03 (study day 220); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-25 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-18 (study day 26); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-31 (study day 161); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-02-28 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-24 (study day 214); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-16 (study day 267); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-25 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-12-02 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 212); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 212); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-04-26 (study day 229); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-05-19 (study day 252); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-06-08 (study day 272); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-08-07 (study day 332); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-08-12 (study day 337); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-06-24 (study day 90); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-18 (study day 114); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-12 (study day 170); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 174); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 286); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 334); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-19 (study day 358); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 563); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-05 (study day 619); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 46); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-06 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-08 (study day 93); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-19 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2022-06-16 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 41); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-17 (study day 97); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 114); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 125); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 261); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-25 (study day 468); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-28 (study day 684); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-02 (study day 750); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-24 (study day 802); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-07 (study day 816); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-17 (study day 826); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-11 (study day 881); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2025-01-03 (study day 965); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 12); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 125); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 332); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-04 (study day 344); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 373); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 382); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-29 (study day 614); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 623); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-17 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-06-30 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-08 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-09 (study day 75); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-04 (study day 101); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-15 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-09-30 (study day 127); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 131); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-27 (study day 185); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-07-24 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 110); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 137); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 182); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 398); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-09 (study day 465); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-22 (study day 631); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-29 (study day 728); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-01 (study day 792); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-10 (study day 151); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-15 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 197); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-01 (study day 139); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 151); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 187); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-02-20 (study day 189); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 234); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 54); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-11-12 (study day 81); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: UNKNOWN; onset 2022-11-20 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 102); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-07 (study day 257); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-29 (study day 340); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 459); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-15 (study day 60); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-25 (study day 70); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-01 (study day 107); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 174); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 319); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-31 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-30 (study day 224); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-15 (study day 300); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 308); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 362); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 480); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 507); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 559); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 47); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 104); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-19 (study day 288); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-02-05 (study day 458); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 466); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-06-01 (study day 575); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: UNKNOWN; onset 2022-11-22 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-24 (study day 49); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 63); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 78); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: UNKNOWN; onset 2023-02-07 (study day 94); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 240); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 392); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-06 (study day 734); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2025-01-12 (study day 771); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 13); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-07 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 87); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-03 (study day 99); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-15 (study day 172); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-26 (study day 183); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 265); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-25 (study day 274); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-18 (study day 328); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-30 (study day 340); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 211); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-10 (study day 277); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-02-04 (study day 363); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-12 (study day 371); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-05-07 (study day 456); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 167); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 212); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-07-29 (study day 531); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-29 (study day 37); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-27 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-27 (study day 157); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-19 (study day 180); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-09 (study day 262); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 287); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-24 (study day 307); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-12 (study day 386); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-11 (study day 446); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-09 (study day 128); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-19 (study day 138); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-01 (study day 181); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-07 (study day 218); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-02 (study day 243); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 297); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 76); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-10 (study day 279); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-30 (study day 420); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-07-12 (study day 463); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-09-11 (study day 524); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2023-08-09 (study day 97); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 129); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-03 (study day 183); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-28 (study day 208); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-08 (study day 249); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 319); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 405); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-20 (study day 443); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-21 (study day 444); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-08-24 (study day 478); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: UNKNOWN; onset 2023-07-08 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-02 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-12 (study day 57); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 87); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 87); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-30 (study day 106); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 111); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-31 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-22 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 101); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 165); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-02-20 (study day 217); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-09 (study day 235); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-04-01 (study day 258); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-05-30 (study day 317); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-03 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-03 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-07 (study day 46); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 66); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-18 (study day 87); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-10-08 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-11 (study day 136); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-11 (study day 136); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-17 (study day 233); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-05-16 (study day 293); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-25 (study day 363); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-19 (study day 388); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-08-26 (study day 395); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 88); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-03-08 (study day 190); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-03-26 (study day 208); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-03-29 (study day 211); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-17 (study day 230); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-05-29 (study day 272); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-29 (study day 364); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 29); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-28 (study day 125); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-05 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-23 (study day 180); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-04-02 (study day 190); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 29); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-08 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 96); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-03-28 (study day 185); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-10 (study day 228); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-16 (study day 295); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-08-24 (study day 334); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 36); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-02-08 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-16 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-11 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2024-05-07 (study day 223); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-07-20 (study day 297); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-09-28 (study day 367); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-09-22 (study day 187); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 204); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: UNKNOWN; onset 2022-12-11 (study day 267); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 451); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 585); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 9); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-13 (study day 25); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-11 (study day 237); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-27 (study day 315); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-18 (study day 456); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 479); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 546); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-03 (study day 594); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-02-29 (study day 682); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 18); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-05-19 (study day 23); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-25 (study day 29); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-06-11 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-06-18 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-12 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-07-12 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-07-15 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2022-10-14 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-31 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-11 (study day 243); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 353); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 361); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-29 (study day 89); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 107); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-21 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 243); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-14 (study day 258); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 260); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 490); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-15 (study day 562); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 574); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 86); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 173); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 248); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 254); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-04-06 (study day 309); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-10 (study day 313); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-02 (study day 335); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-06-03 (study day 733); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-18 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 188); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-05 (study day 212); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-08 (study day 366); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-14 (study day 372); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-27 (study day 216); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 367); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 401); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 645); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-24 (study day 699); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-06 (study day 742); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2024-07-07 (study day 743); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-24 (study day 455); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-04 (study day 496); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-22 (study day 514); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-27 (study day 611); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-24 (study day 698); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-11-07 (study day 865); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 170); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 227); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-25 (study day 295); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-28 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 140); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-30 (study day 241); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 369); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-30 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 71); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-06 (study day 73); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 116); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-29 (study day 126); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 141); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: UNKNOWN; onset 2022-11-12 (study day 78); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-20 (study day 86); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-20 (study day 147); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-26 (study day 65); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 270); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-23 (study day 274); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-09 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 146); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-13 (study day 200); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: UNKNOWN; onset 2024-03-18 (study day 540); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 552); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-10-24 (study day 13); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-11 (study day 31); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-10 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-16 (study day 168); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 252); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 290); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 316); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 366); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 471); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: UNKNOWN; onset 2023-03-19 (study day 73); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 240); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-17 (study day 408); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-10 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-02-05 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-11 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 49); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-02-01 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-03 (study day 38); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 57); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-15 (study day 109); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 242); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-14 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-25 (study day 424); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-19 (study day 479); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-08-27 (study day 487); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 54); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 174); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 221); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-05-17 (study day 382); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-18 (study day 444); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-24 (study day 268); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-10-22 (study day 540); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 136); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-06-29 (study day 404); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-01 (study day 406); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-08-10 (study day 446); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-03 (study day 30); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-04 (study day 335); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-02 (study day 364); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-08-11 (study day 373); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-16 (study day 378); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-08-24 (study day 386); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-08-28 (study day 390); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-28 (study day 421); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 28); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 111); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-16 (study day 164); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-09-23 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 69); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-20 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 80); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-22 (study day 169); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 202); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-16 (study day 254); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-03 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 16); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-02 (study day 38); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-10 (study day 138); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 172); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-17 (study day 176); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 215); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-30 (study day 340); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-22 (study day 130); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-06-19 (study day 279); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-07-09 (study day 299); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-11-08 (study day 421); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: UNKNOWN; onset 2024-12-14 (study day 457); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 80); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-31 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-25 (study day 188); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-15 (study day 209); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 29); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-01 (study day 40); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 209); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-10 (study day 232); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: UNKNOWN; onset 2022-08-14 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-15 (study day 137); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 139); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-09-25 (study day 147); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 148); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-17 (study day 16); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 77); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-16 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-07-19 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 64); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-30 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 121); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-05 (study day 122); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-25 (study day 172); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 196); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 261); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-04 (study day 272); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 220); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 243); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-06 (study day 323); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-01-27 (study day 558); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-05-14 (study day 666); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-07-09 (study day 722); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-07-26 (study day 739); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-11-19 (study day 855); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 43); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 359); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-29 (study day 387); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 390); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 467); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 496); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-09 (study day 580); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 605); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-02 (study day 634); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: UNKNOWN; onset 2022-09-22 (study day 12); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-08 (study day 28); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-24 (study day 44); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-27 (study day 47); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-27 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-01 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 70); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 70); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-29 (study day 49); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-27 (study day 139); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-28 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-21 (study day 375); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-05-10 (study day 577); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-15 (study day 674); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-01 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 91); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-28 (study day 93); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 200); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-09 (study day 286); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-28 (study day 22); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 195); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 268); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-13 (study day 402); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 487); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-05-02 (study day 543); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 5); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-14 (study day 6); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 9); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 14); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-23 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-26 (study day 18); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-01 (study day 23); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 284); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-23 (study day 409); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-28 (study day 536); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-10-08 (study day 699); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-29 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-03 (study day 37); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 65); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-02-27 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 97); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-13 (study day 117); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 119); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-06-01 (study day 166); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-02 (study day 8); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 15); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-10 (study day 16); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 41); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2023-03-05 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-30 (study day 95); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-11 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-12 (study day 249); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 340); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-07-26 (study day 537); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-29 (study day 540); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-05 (study day 578); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-09-28 (study day 601); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-11-22 (study day 656); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 70); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-24 (study day 317); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2024-01-17 (study day 341); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 349); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-10 (study day 365); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-25 (study day 440); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-27 (study day 442); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-29 (study day 444); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 53); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 87); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 102); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-23 (study day 116); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-26 (study day 119); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 122); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-14 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-20 (study day 51); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-28 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 64); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-05 (study day 66); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 82); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 103); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-07 (study day 191); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-09 (study day 193); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 26); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 103); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 150); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-25 (study day 183); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 213); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-03 (study day 314); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-03 (study day 343); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-06 (study day 407); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-05-12 (study day 413); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 12); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-27 (study day 150); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-15 (study day 260); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-19 (study day 82); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 216); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 254); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 312); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-13 (study day 350); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-05-16 (study day 353); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-05-18 (study day 355); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-08-02 (study day 431); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 23); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-12 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 44); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 73); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 76); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-13 (study day 96); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 193); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-04 (study day 205); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-04-15 (study day 276); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 365); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-15 (study day 367); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: UNKNOWN; onset 2024-02-18 (study day 202); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-16 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-03 (study day 98); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-18 (study day 113); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 125); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-16 (study day 202); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 129); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-01 (study day 257); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-09-25 (study day 373); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-10-09 (study day 387); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-12-10 (study day 449); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-12 (study day 451); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-12-23 (study day 462); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2025-01-01 (study day 471); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-28 (study day 34); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-23 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-01-04 (study day 102); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-19 (study day 115); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-12 (study day 168); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-04 (study day 221); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2024-09-21 (study day 361); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-10-03 (study day 373); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-10-25 (study day 395); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-11-23 (study day 424); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-13 (study day 444); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 145); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-31 (study day 179); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 388); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-23 (study day 317); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 415); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 469); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-06 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-30 (study day 195); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-12-30 (study day 256); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 266); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-16 (study day 25); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 30); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-06-17 (study day 57); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 236); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-31 (study day 254); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 303); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 341); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-02 (study day 376); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-11 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-05-30 (study day 24); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-07-03 (study day 58); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 235); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 252); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 309); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-12 (study day 341); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-07 (study day 366); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 536); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-06-19 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-17 (study day 46); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-08-23 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 86); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-24 (study day 115); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-07 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 203); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-31 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-01 (study day 54); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-24 (study day 138); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2022-11-01 (study day 146); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-22 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2023-02-12 (study day 249); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 376); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 455); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-09 (study day 458); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 11); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-29 (study day 12); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-20 (study day 34); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 50); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 59); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-08-27 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-08-28 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-31 (study day 39); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-26 (study day 95); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 186); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-22 (study day 91); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-10-28 (study day 97); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 108); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 167); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 344); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-14 (study day 509); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-28 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-15 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: UNKNOWN; onset 2022-10-20 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 149); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 191); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 192); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 195); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-12 (study day 196); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 42); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 131); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 236); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 269); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 363); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 423); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-11 (study day 521); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-05 (study day 668); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-09-13 (study day 707); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-20 (study day 744); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: UNKNOWN; onset 2022-10-29 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 25); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-31 (study day 84); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 222); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-08 (study day 273); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-28 (study day 293); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 70); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-25 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 144); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 195); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2023-05-17 (study day 220); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-18 (study day 313); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 318); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 523); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-06-22 (study day 622); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-26 (study day 171); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 210); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-04 (study day 515); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-05-20 (study day 561); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-10-08 (study day 702); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2025-01-08 (study day 794); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 7); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-11 (study day 45); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-02-07 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 165); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 270); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 44); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-02-14 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 81); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 196); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-06-26 (study day 166); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-02 (study day 356); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 365); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 409); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: UNKNOWN; onset 2024-03-07 (study day 421); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-28 (study day 595); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-20 (study day 679); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-30 (study day 77); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 86); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 86); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-28 (study day 136); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-07-11 (study day 149); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 155); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 313); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 57); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-06 (study day 79); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-19 (study day 153); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-28 (study day 193); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 197); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-18 (study day 214); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-22 (study day 218); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 32); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-13 (study day 73); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 269); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 380); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-07 (study day 433); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-26 (study day 544); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-09-10 (study day 559); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-29 (study day 639); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-19 (study day 659); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-26 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 142); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-27 (study day 146); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-03 (study day 153); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-30 (study day 241); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 91); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 100); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-08 (study day 239); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-13 (study day 274); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 288); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-07 (study day 15); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-06 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 78); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 87); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-28 (study day 97); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 9); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 19); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 37); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 39); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: UNKNOWN; onset 2023-05-25 (study day 43); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 49); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-06-10 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-16 (study day 65); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-02 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 22); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-04 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-10-08 (study day 161); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-12 (study day 226); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-06-14 (study day 411); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 67); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: UNKNOWN; onset 2023-08-12 (study day 100); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 102); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-26 (study day 114); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-30 (study day 149); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 154); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-09 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-04 (study day 79); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 318); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-04-24 (study day 343); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-02 (study day 412); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-10-23 (study day 525); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2025-01-03 (study day 597); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-10-03 (study day 65); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: UNKNOWN; onset 2024-01-28 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-12 (study day 197); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: UNKNOWN; onset 2024-02-19 (study day 204); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-11 (study day 225); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-12-10 (study day 499); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-03-17 (study day 13); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-07 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 39); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 72); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 132); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-05 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-16 (study day 469); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-02-19 (study day 717); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 761); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2022-04-10 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-19 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 220); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-07 (study day 238); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 270); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-20 (study day 312); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 336); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 359); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: UNKNOWN; onset 2023-04-17 (study day 399); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-03-22 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-12 (study day 55); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-20 (study day 94); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-04 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-16 (study day 151); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-02 (study day 168); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-04 (study day 170); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-11-26 (study day 248); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 317); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-20 (study day 334); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 344); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 418); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 420); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 2); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 9); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-05-23 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-06-04 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 294); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 408); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 455); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-29 (study day 499); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 591); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 630); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-21 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-18 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 285); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-03-25 (study day 295); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 460); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-07 (study day 583); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 587); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: UNKNOWN; onset 2024-07-05 (study day 763); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-07 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-23 (study day 147); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 198); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-01-28 (study day 213); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 237); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 294); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-09 (study day 463); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-08 (study day 554); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 601); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 613); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-03-11 (study day 617); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-13 (study day 619); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-13 (study day 619); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-07-07 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-07-22 (study day 17); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 22); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-08-01 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 60); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-14 (study day 360); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 363); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-14 (study day 575); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-10-02 (study day 806); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-11-13 (study day 848); relationship: not assessed; serious criteria: hospitalization
moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 27); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 348); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-16 (study day 557); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-10-17 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-25 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 171); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 328); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: UNKNOWN; onset 2023-10-14 (study day 386); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-20 (study day 453); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-25 (study day 458); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-02 (study day 466); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-19 (study day 543); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-11 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-10-18 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-07 (study day 71); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 79); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2023-02-21 (study day 147); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 151); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-04 (study day 154); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 195); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 263); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-04 (study day 276); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 324); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 493); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-22 (study day 509); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-06 (study day 522); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: UNKNOWN; onset 2022-12-31 (study day 60); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-21 (study day 81); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 167); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 228); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-11 (study day 405); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 425); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 469); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-01 (study day 486); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-03-08 (study day 493); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 515); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 81); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 114); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 192); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-15 (study day 251); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-12-16 (study day 32); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 40); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-11 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2023-04-07 (study day 96); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 144); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-12 (study day 162); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-08 (study day 188); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 203); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 225); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-22 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: UNKNOWN; onset 2023-04-01 (study day 73); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 194); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-02-09 (study day 19); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 114); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 159); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-22 (study day 182); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 204); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-18 (study day 270); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-12 (study day 325); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-15 (study day 328); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-03 (study day 378); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 539); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 43); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-12 (study day 315); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 498); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-02-10 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-19 (study day 6); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 33); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-07 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 146); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-07 (study day 175); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-08 (study day 207); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 30); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-25 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 50); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-08 (study day 118); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-11 (study day 121); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-24 (study day 134); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-20 (study day 278); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-23 (study day 281); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-29 (study day 378); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-08-03 (study day 505); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-14 (study day 290); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 299); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 313); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 331); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 367); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-06 (study day 373); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-24 (study day 100); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 121); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-29 (study day 228); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-05 (study day 234); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-14 (study day 243); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-25 (study day 254); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-01-18 (study day 278); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-22 (study day 95); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 119); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-23 (study day 188); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-13 (study day 239); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-05-01 (study day 348); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-16 (study day 547); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-07-26 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-08 (study day 91); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-09-08 (study day 91); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-20 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-22 (study day 350); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-04 (study day 360); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-16 (study day 433); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-01 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-08 (study day 95); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 140); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 228); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 279); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-30 (study day 421); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-21 (study day 565); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-26 (study day 601); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-05-16 (study day 42); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 53); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 110); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-20 (study day 169); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-05-02 (study day 5); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-02 (study day 5); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-05-05 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 17); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 18); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-26 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-31 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-06-02 (study day 36); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2022-06-07 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-21 (study day 40); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-07-06 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-15 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 217); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-29 (study day 231); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 258); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 56); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 95); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-11 (study day 119); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 32); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-12-26 (study day 86); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-12 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 116); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: UNKNOWN; onset 2023-04-25 (study day 206); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 348); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-22 (study day 15); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-23 (study day 47); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 72); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-25 (study day 9); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-16 (study day 31); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-09 (study day 54); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-17 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-23 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 72); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-10 (study day 195); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 205); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-22 (study day 299); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-13 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-29 (study day 367); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-22 (study day 452); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: UNKNOWN; onset 2022-12-12 (study day 40); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 108); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-02-21 (study day 111); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-19 (study day 137); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-04-07 (study day 156); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-24 (study day 203); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-11 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 143); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 256); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 267); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 288); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-05 (study day 401); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 28); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 48); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: UNKNOWN; onset 2023-02-22 (study day 84); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-22 (study day 12); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-14 (study day 35); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 43); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 86); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 87); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-25 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 183); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 193); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-21 (study day 38); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 201); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: UNKNOWN; onset 2023-08-09 (study day 238); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 265); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-12 (study day 302); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 317); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-24 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 94); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-07 (study day 104); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-28 (study day 369); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-09 (study day 381); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: UNKNOWN; onset 2023-01-08 (study day 2); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 38); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 61); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-21 (study day 74); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-21 (study day 14); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 23); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-03 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-12 (study day 64); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-02-18 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-04-08 (study day 67); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 181); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 13); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 254); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-28 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-02-01 (study day 356); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-16 (study day 122); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-25 (study day 131); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 188); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 191); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 213); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-04 (study day 42); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-22 (study day 60); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-08 (study day 76); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-28 (study day 157); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 196); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-09-19 (study day 210); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 271); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-17 (study day 330); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-13 (study day 23); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-04-13 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 76); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 93); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-19 (study day 120); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-22 (study day 123); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 104); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 110); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 186); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 207); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-03 (study day 310); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-21 (study day 328); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-06 (study day 435); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-07 (study day 436); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-08-18 (study day 478); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 25); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-27 (study day 84); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 88); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-07 (study day 95); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 180); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-11-09 (study day 189); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-10 (study day 190); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-01-16 (study day 257); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-18 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-08-30 (study day 118); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-02 (study day 151); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-12 (study day 253); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: UNKNOWN; onset 2024-01-28 (study day 269); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-06-03 (study day 396); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 7); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-21 (study day 122); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 234); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-03 (study day 408); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-14 (study day 450); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-08-19 (study day 455); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-09-12 (study day 479); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious reported on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-12-07 (study day 565); relationship: N; serious criteria: life-threatening
moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-10 (study day 199); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-24 (study day 213); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 229); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 293); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-07-05 (study day 316); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-07-25 (study day 336); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-10-21 (study day 43); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-26 (study day 48); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-03 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-30 (study day 296); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-09-07 (study day 365); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-09-15 (study day 373); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 3); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 3); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-02 (study day 84); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-30 (study day 204); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 213); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 227); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-15 (study day 54); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-05 (study day 136); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 180); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 253); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-12 (study day 416); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 476); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-08-18 (study day 71); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-13 (study day 127); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-02 (study day 177); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 345); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-27 (study day 811); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2025-01-07 (study day 944); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-07-30 (study day 12); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-08-07 (study day 20); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-11 (study day 55); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-29 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2022-10-29 (study day 98); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-31 (study day 100); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-11-03 (study day 103); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 110); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 226); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-13 (study day 539); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-28 (study day 614); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-12 (study day 629); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-04-29 (study day 646); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 27); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 29); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: UNKNOWN; onset 2022-10-16 (study day 82); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 130); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 131); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-10-05 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-18 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 77); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 122); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-22 (study day 202); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 121); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: UNKNOWN; onset 2023-05-23 (study day 291); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-15 (study day 344); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 499); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 509); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-09-09 (study day 23); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-02-11 (study day 178); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: UNKNOWN; onset 2023-02-28 (study day 195); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 245); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 478); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-18 (study day 488); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-14 (study day 515); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-28 (study day 560); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-14 (study day 51); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-07 (study day 256); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-25 (study day 305); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 323); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 351); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-01 (study day 464); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-15 (study day 24); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 53); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 57); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 61); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-28 (study day 68); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-01 (study day 71); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 17); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 94); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 208); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-07-14 (study day 265); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-11 (study day 324); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 14); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-05 (study day 32); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-14 (study day 41); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-13 (study day 71); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 88); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 37); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-26 (study day 103); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 123); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 103); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 108); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 110); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 112); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: UNKNOWN; onset 2023-02-12 (study day 2); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-04-03 (study day 52); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-14 (study day 63); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 68); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-10 (study day 89); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 192); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-06 (study day 269); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-22 (study day 285); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 185); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 214); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 236); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-04 (study day 244); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-22 (study day 262); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-17 (study day 318); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-16 (study day 377); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 34); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-23 (study day 69); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-08 (study day 85); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 120); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-24 (study day 193); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-06 (study day 236); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-02 (study day 262); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 269); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-19 (study day 310); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 31); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-05-14 (study day 57); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 159); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-04 (study day 170); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 172); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 210); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 284); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-19 (study day 398); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-20 (study day 429); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-23 (study day 432); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 4); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 18); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-26 (study day 41); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-26 (study day 41); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-05 (study day 51); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-25 (study day 71); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 122); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 210); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-15 (study day 391); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-19 (study day 55); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 78); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-14 (study day 234); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 4); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 27); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-16 (study day 33); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-07-18 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 105); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 113); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 201); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-11 (study day 212); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 8); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-12 (study day 110); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-15 (study day 205); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-20 (study day 210); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-28 (study day 23); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-04 (study day 30); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-11 (study day 98); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 157); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 164); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-25 (study day 14); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 30); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 69); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-10 (study day 152); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-25 (study day 39); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 58); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 71); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-09 (study day 84); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 127); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-12 (study day 148); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-28 (study day 164); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 59); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-10-26 (study day 69); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 75); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 114); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-23 (study day 127); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-26 (study day 161); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-14 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-20 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 36); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-15 (study day 77); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-01 (study day 93); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-09 (study day 101); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 5); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 41); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-11-11 (study day 50); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 144); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-04 (study day 225); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 56); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 77); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 86); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-06-25 (study day 115); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 118); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 143); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-08-13 (study day 164); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-05-31 (study day 89); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2022-06-24 (study day 113); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-15 (study day 165); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 176); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-31 (study day 181); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 244); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-04 (study day 120); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-21 (study day 168); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-22 (study day 200); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-10-23 (study day 231); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-12 (study day 46); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-25 (study day 120); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 162); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-06 (study day 163); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 226); relationship: Y; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 309); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-11 (study day 321); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-08 (study day 124); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-07 (study day 154); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 498); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-16 (study day 27); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-11 (study day 53); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-12 (study day 54); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-07-13 (study day 85); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-08 (study day 111); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-09 (study day 112); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-09-10 (study day 144); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-10-17 (study day 181); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 15); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 15); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-30 (study day 183); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-08-15 (study day 472); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 633); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-04-13 (study day 714); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-09 (study day 97); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 114); relationship: not assessed; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 192); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-05 (study day 215); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-14 (study day 255); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 321); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 423); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 445); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 541); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 80); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 146); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-12 (study day 150); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 247); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 276); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 359); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 370); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-11 (study day 148); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-01 (study day 230); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 347); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-03-01 (study day 624); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-03-04 (study day 627); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 650); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-30 (study day 22); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-08-11 (study day 34); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-08-12 (study day 35); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-08-15 (study day 38); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-14 (study day 21); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 65); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 132); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 156); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-30 (study day 159); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-08-12 (study day 19); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-18 (study day 25); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 55); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-11-19 (study day 118); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 121); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-27 (study day 126); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-02 (study day 131); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 12); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 133); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-03-12 (study day 214); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 217); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 327); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-03 (study day 121); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 520); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-04-04 (study day 578); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 3); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 43); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-25 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 70); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-16 (study day 90); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 130); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 155); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-15 (study day 179); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-20 (study day 184); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 134); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 152); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-14 (study day 203); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-17 (study day 206); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 241); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 28); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 56); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 68); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 120); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-05 (study day 123); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: UNKNOWN; onset 2023-03-27 (study day 145); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 228); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 240); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 27); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-01-16 (study day 46); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 47); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: UNKNOWN; onset 2023-02-03 (study day 64); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-22 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 86); relationship: N; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 99); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 102); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-04 (study day 56); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-17 (study day 69); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 157); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-08-04 (study day 209); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-19 (study day 285); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-24 (study day 290); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-16 (study day 343); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-23 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 68); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-22 (study day 69); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 78); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-03 (study day 81); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 10); relationship: N; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-10 (study day 39); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-22 (study day 509); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-29 (study day 516); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-12-10 (study day 619); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 20); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-07-28 (study day 69); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-08-20 (study day 92); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-21 (study day 50); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 73); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-11-04 (study day 156); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-06 (study day 188); relationship: not assessed; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-07 (study day 189); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 209); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 212); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-01 (study day 214); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 251); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-08 (study day 11); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-09-17 (study day 82); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-18 (study day 83); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-18 (study day 205); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-05-07 (study day 315); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-03 (study day 372); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-10-28 (study day 489); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-12-30 (study day 552); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-02 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 52); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-23 (study day 59); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 62); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-30 (study day 66); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-06 (study day 72); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 153); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-03-22 (study day 240); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-26 (study day 44); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-10-12 (study day 60); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-05-19 (study day 280); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-31 (study day 384); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-28 (study day 9); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-03 (study day 15); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-09-08 (study day 20); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-13 (study day 25); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Diarrhoea — outcome: UNKNOWN; onset 2023-10-12 (study day 54); relationship: Y

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 75); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 75); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 75); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

severe assessed on Torivumab Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 43); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-04-16 (study day 238); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-03 (study day 255); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-28 (study day 7); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-03 (study day 12); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-20 (study day 29); relationship: N

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-13 (study day 53); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 74); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

severe serious assessed on Torivumab Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 74); relationship: Y; serious criteria: life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 80); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

moderate assessed on Torivumab Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-12 (study day 113); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

mild assessed on Torivumab Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-24 (study day 125); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

Clinical data management — EDC queries (0)

No data queries.