Operations dashboard

OVERDUE SAE — SAE Narrative Subject P2B-132 (46-year-old male), enrolled in the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm, experienced a serious adverse event of Cholecystitis (System Organ Class: Hepatobiliary disorders), assessed as Grade 3 in severity. The event met the criterion of seriousness due to hospitalization. Onset occurred on 2013-09-29, with resolution on 2013-10-13, for a total duration of 14 days. The outcome was reported as RECOVERED/RESOLVED. The investigator's causality assessment was UNLIKELY (not suspected as related to study treatment). No dose adjustment was made as a result of this event (action taken with study treatment: DOSE NOT CHANGED). This event was classified as unexpected, as it is not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). As an unexpected serious adverse event assessed as not related to study drug, expedited reporting was required within 15 days per ICH E2A guidelines, with a due date of 2013-10-14. This report is OVERDUE. Death within 30 days of the event: No. Additional Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — SAE Narrative – Subject P2B-130 Subject P2B-130 is a 51-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (Grade 3), System Organ Class: Blood and lymphatic system disorders, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-17, with resolution documented on 2013-11-10, corresponding to a duration of 24 days. The outcome was reported as RECOVERED/RESOLVED. Following the onset of the event, the action taken with study treatment was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Per ICH E2A expedited reporting requirements, this event triggered a 15-day reporting clock, with an expedited report due on 2013-11-01. This report is OVERDUE. Death within 30 days of the event: No. Additional source description: Grade 3 Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — SAE Narrative Subject P2B-134 is a 66-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-22. The event resolved on 2013-11-26, with an event duration of 35 days. The outcome was reported as RECOVERED/RESOLVED. As a result of the event, the following action was taken with study treatment: DOSE REDUCED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. Expectedness assessment: unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory reporting: This event met criteria for expedited reporting under a 15-day timeline (ICH E2A). The expedited report was due on 2013-11-06. Based on the information provided, this report is OVERDUE. Additional narrative detail from source Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-134 is a 66-year-old female enrolled in the study, assigned to the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm. The subject experienced a serious adverse event of Febrile neutropenia (System Organ Class: Blood and lymphatic system disorders), graded as Grade 4 in severity. The event met seriousness criteria on the basis of hospitalization. Onset of the event occurred on 2013-10-29, with resolution documented on 2013-11-04, for a total event duration of 6 days. The outcome was reported as RECOVERED/RESOLVED. In response to the event, study treatment action taken was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. The event was assessed as unexpected, as it is not listed on the doxorubicin hydrochloride label (used as a doxorubicin class proxy reference). Regulatory reporting: Per the applicable expedited reporting clock (15 days, consistent with ICH E2A for other serious unexpected suspected adverse reactions), the exp Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-129 is a 64-year-old female enrolled in the study arm receiving Doxorubicin 75 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset occurred on 2013-10-30, with cycle 5 onset noted in the source description. The event resolved on 2013-12-02, resulting in an event duration of 33 days. As a result of the event, study treatment action taken was: drug interrupted. The event outcome was recorded as RECOVERED/RESOLVED. The investigator's causality assessment was PROBABLE, and the causality category was classified as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory Reporting Status: Per ICH E2A guidelines, this event met criteria for expedited reporting under the 15-day serious unexpected reaction timeline. The expedited report was due on 2013-11-14. This report is Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject SITE001-0066 (58-year-old male) experienced a serious adverse event graded as Grade 3 in severity. The event term has not yet been coded; system organ class is [PENDING — human input]. Source information: Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning." This is a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input]. Treatment arm: withheld, as the study remains blinded. Action taken with study treatment: [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — SAE Narrative Subject SITE012-0012 (58-year-old male) experienced a serious adverse event of Grade 3 Diarrhoea (System Organ Class: Gastrointestinal disorders), meeting seriousness criteria of hospitalization. Onset date: 2026-08-20. Resolution date: 2026-08-30. Outcome: RECOVERED/RESOLVED. Study treatment arm: withheld — study is blinded. Action taken with study treatment: DRUG WITHDRAWN. Causality assessment: Investigator causality assessment has not been completed. [PENDING — human input] Expectedness: Reported as expected for the anti-PD-1 class per the pembrolizumab label. Expedited reporting: Expedited due date on record is 2026-09-04. This deadline appears to be OVERDUE based on the data provided. Although the event is described as label-listed, confirmation is required from the physician as to whether expedited reporting still applies. [PENDING — human input] Death within 30 days: No. Additional source description on file: Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 ( Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — Subject SITE013-0278 (64-year-old F) experienced Grade 3 Asthenia (General disorders and administration site conditions), serious (hospitalization). Onset 2026-08-30; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-14 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

OVERDUE SAE — Subject SITE015-0227 (61-year-old M) experienced Grade 3 Neutropenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-01; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DRUG WITHDRAWN. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-16 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

OVERDUE SAE — Subject SITE007-0138 (59-year-old F) experienced Grade 4 Fatigue (General disorders and administration site conditions), serious (life-threatening). Onset 2026-09-02, resolved 2026-09-13 (11 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality RELATED (suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-17 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE012-0203 (60-year-old male) experienced a serious adverse event of Diarrhoea (Grade 3, System Organ Class: Gastrointestinal disorders). The event met serious Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — Subject SITE005-0273 (79-year-old F) experienced Grade 3 Thrombocytopenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-05; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality not assessed — investigator assessment required. Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — Subject SITE006-0258 (61-year-old M) experienced Grade 3 Nausea (Gastrointestinal disorders), serious (hospitalization). Onset 2026-09-05, resolved 2026-09-10 (5 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE007-0231 (46-year-old male) experienced a Grade 3 serious adverse event of Adrenal insufficiency (System Organ Class: Endocrine disorders). The event met seriousness criteria due to hosp Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject SITE015-0186 (50-year-old male) experienced a serious adverse event of Constipation (Gastrointestinal disorders), Grade 4, assessed as serious due to life-threatening criteria. Onset: 2026-09-10. Outcome at time of reporting: NOT RECOVERED/NOT RESOLVED. Note: The source description associated with this event records onset as 2023-03-06 (study day 134) and outcome as RECOVERED/RESOLVED, which conflicts with the onset and outcome fields above. This discrepancy has not been resolved in the Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — Subject SITE001-0119 (62-year-old M) experienced Grade 4 Neutropenia (Blood and lymphatic system disorders), serious (life-threatening). Onset 2026-09-13; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE NOT CHANGED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-28 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE011-0239 (49-year-old female) experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, meeting seriousness criteria of hospitalization. Per the structured event data, onset occurred on 2026-09-13 and the event is ongoing, with an outcome of NOT RECOVERED/N Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject NCT03016819-P02 is a 39-year-old female enrolled in treatment arm Placebo (LMS). The subject experienced an adverse event classified as Grade 3 and reported as serious. The event term has not yet been coded; system organ class is [PENDING — human input]. Source of information: Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization. Onset date: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Action taken with study treatment: [PENDING — human input] Causality: Investigator causality assessment has not been performed. Causality category is currently unassessed. Investigator causality assessment required before this narrative can be finalized. Expectedness: Expectedness undetermined — event has not yet been coded against the reference safety information. Death within 30 days of event: No. Regulatory reporting: This event has been identified as meeting criteria for expedited reporting under a 15-day timeline (ICH E2A, other serious unexpected event category). The expedited report is due on 2026-10-23. Additional clin [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject NCT03016819-P02 is a 39-year-old female enrolled in the Placebo (LMS) arm who experienced a serious adverse event, Grade 3 in severity. Event term: [PENDING — human input] (event not yet coded). System organ class: [PENDING — human input]. Onset date: [PENDING — human input]. Source/reported description: Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization. Action taken with study treatment: [PENDING — human input]. Outcome: [PENDING — human input]. Date of resolution (if applicable): [PENDING — human input]. Investigator causality assessment: not assessed — investigator assessment required. Causality category on file: unassessed. Expectedness: expectedness undetermined — event not yet coded. Death within 30 days of event: No. Regulatory reporting: This event meets criteria for expedited reporting under ICH E2A as a serious, other unexpected event, subject to a 15-day reporting clock. Expedited report due on 2026-10-23. Narrative summary: A 39-year-old female subject in the Placebo (LMS) arm experienced a [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject NCT07705334-P02 is a 57-year-old female enrolled in study NCT07705334, treatment arm: [PENDING — human input]. The subject experienced a serious adverse event (Grade 3), currently uncoded, as reported via participant-reported source: Luna chat message, "I've had a high fever since last night." This was a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Death within 30 days of event: No Causality: Investigator causality assessment has not yet been recorded. [PENDING — human input] Expectedness: Expectedness undetermined — event not yet coded. [PENDING — human input] Regulatory Reporting: This event has been classified as serious. Per ICH E2A requirements, an expedited report is due on 2026-10-23, consistent with the 15-day reporting clock applicable to other serious unexpected events. This narrative will be updated upon receipt of additional clinical information, including invest [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject NCT07705334-P02 (57-year-old female; treatment arm: [PENDING — human input]) experienced a serious adverse event, Grade 3 in severity. The event has not yet been coded; the uncoded term is based on participant-reported information via Luna chat ("high fever"), a solicited symptom report that requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Investigator causality assessment: not assessed — investigator assessment required. Expectedness: expectedness undetermined — event not yet coded. Seriousness: serious. Death within 30 days of event: no. Regulatory reporting: This event falls under the 15-day expedited reporting timeline (other serious, unexpected) per ICH E2A. The expedited report is due on 2026-10-23. Additional clinical details, including a fully characterized diagnosis, SOC/coded term, and investigator causality assessment, are pending and required prior to finalization of this narrative. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Study arm: [PENDING — human input] Event: Adverse event, not yet coded (System Organ Class: [PENDING — human input]) Seriousness: Serious Severity grade: Grade 3 Onset date: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Action taken: [PENDING — human input] Source information: Participant-reported via Luna chat: "I've had a high fever since last night." This is a solicited symptom report and requires clinical characterization. Causality ass [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Treatment Arm: [PENDING — human input] Event Description: Adverse event, not yet coded (System Organ Class: [PENDING — human input]). The event was reported as serious and graded as Grade 3 in severity. Source of Report: Participant-reported via Luna chat: "high fever." This is a solicited symptom report and requires clinical characterization. Onset Date: [PENDING — human input] Outcome: [PENDING — human input] [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT06975293-P02 Sex: F Age: 31 Treatment arm: STC-15 monotherapy (sarcoma) Event: Adverse event (uncoded; system organ class not yet assigned: [PENDING — human input]) Seriousness: Serious Grade (severity): Grade 3 Onset date: [PENDING — human input] Source/description: Participant-reported via Luna chat: "I've had a high fever since last night." Solicited symptom report; requires clinical characterization. Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Causality assessment (investigator): [PENDING — human [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT06975293-P02 (31-year-old female), enrolled in the STC-15 monotherapy (sarcoma) treatment arm. Event: The subject experienced an adverse event, currently uncoded, graded as Grade 3 and classified as serious. System organ class: [PENDING — human input]. Source: Event was participant-reported via Luna chat, described as "high fever." This is a solicited symptom report that requires clinical characterization. [PENDING — human input] Onset: Onset date not recorded. [PENDING — human input] Causality: Investigator causality assessment has not been completed. Causality category: unassessed. [PEND [narrative drafted by claude-sonnet-5; verify against source fields]