Data, safety & analytics
Every reported event is attributable to a study and the therapy under development. Serious events sort first so the expedited-reporting clock is never buried. "Mechanism literature" links an event to published evidence connecting the drug class to the reported effect.
Pharmacovigilance — adverse events 69 in view
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 81); relationship: not assessed; serious criteria: hospitalization
Grade 3 Anaemia (Blood and lymphatic system disorders), serious (hospitalization), causality not assessed — investigator assessment required, 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: NOT RELATED; serious criteria: life-threatening
Grade 4 Neutropenia (Blood and lymphatic system disorders), serious (life-threatening), causality NOT RELATED (not suspected), 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 134); relationship: RELATED; serious criteria: life-threatening
Grade 4 Constipation (Gastrointestinal disorders), serious (life-threatening), causality RELATED (suspected), expected for anti-PD-1 class per pembrolizumab label, existing expedited deadline 2026-09-25 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization
Grade 3 Adrenal insufficiency (Endocrine disorders), serious (hospitalization), causality not assessed — investigator assessment required, expected for anti-PD-1 class per pembrolizumab label, existing expedited deadline 2026-09-21 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 53); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Nausea (Gastrointestinal disorders), serious (hospitalization), causality NOT RELATED (not suspected), 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 30); relationship: not assessed; serious criteria: hospitalization
Grade 3 Thrombocytopenia (Blood and lymphatic system disorders), serious (hospitalization), causality not assessed — investigator assessment required, 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 114); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea (Gastrointestinal disorders), serious (hospitalization), causality not assessed — investigator assessment required, expected for anti-PD-1 class per pembrolizumab label, existing expedited deadline 2026-09-19 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — under safety physician review (triage only; causality and closure are the physician's)
Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: RELATED; serious criteria: life-threatening
Grade 4 Fatigue (General disorders and administration site conditions), serious (life-threatening), causality RELATED (suspected), 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 86); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Neutropenia (Blood and lymphatic system disorders), serious (hospitalization), causality NOT RELATED (not suspected), 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 13); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Asthenia (General disorders and administration site conditions), serious (hospitalization), causality NOT RELATED (not suspected), 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 — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 336); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea (Gastrointestinal disorders), serious (hospitalization), causality not assessed — investigator assessment required, expected for anti-PD-1 class per pembrolizumab label, existing expedited deadline 2026-09-04 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 anaemia with onset in cycle 5 (2013-10-30); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-12-02; action: drug interrupted.
Grade 3 Anaemia (Blood and lymphatic system disorders), serious (hospitalization), causality PROBABLE (suspected), unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy), expedited report due 2013-11-14 (15-day other serious unexpected clock, ICH E2A) — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Grade 4 febrile neutropenia with onset in cycle 5 (2013-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-04; action: drug interrupted.
Grade 4 Febrile neutropenia (Blood and lymphatic system disorders), serious (hospitalization), causality PROBABLE (suspected), unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy), expedited report due 2013-11-13 (15-day other serious unexpected clock, ICH E2A) — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 anaemia with onset in cycle 5 (2013-10-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-26; action: dose reduced.
Grade 3 Anaemia (Blood and lymphatic system disorders), serious (hospitalization), causality PROBABLE (suspected), unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy), expedited report due 2013-11-06 (15-day other serious unexpected clock, ICH E2A) — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 anaemia with onset in cycle 4 (2013-10-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-10; action: drug interrupted.
Grade 3 Anaemia (Blood and lymphatic system disorders), serious (hospitalization), causality PROBABLE (suspected), unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy), expedited report due 2013-11-01 (15-day other serious unexpected clock, ICH E2A) — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Grade 3 cholecystitis with onset in cycle 4 (2013-09-29); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-10-13.
Grade 3 Cholecystitis (Hepatobiliary disorders), serious (hospitalization), causality UNLIKELY (not suspected), unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy), expedited report due 2013-10-14 (15-day other serious unexpected clock, ICH E2A) — OVERDUE — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-23 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning". Solicited symptom report; requires clinical characterization.
Grade 3 adverse event, serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded, expedited report due 2026-10-04 (15-day other serious unexpected clock, ICH E2A) — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this week and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've been feeling tired lately, should I tell the screening team?". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've been feeling tired lately, should I tell the screening team?". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this week and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this week and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "I've been feeling tired lately, should I tell the screening team?". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Honestly the trips to the clinic leave me exhausted". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "The fatigue is a bit better today, thank you". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Participant-reported via Luna chat: "Some nausea this evening and my appetite is down". Solicited symptom report logged for the next visit review.
Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)
Clinical data management — EDC queries 9
AE Anaemia (grade 1) for SITE010-0221 has onset 2026-06-05, 1 d before first dose on 2026-06-06. Confirm onset date or record as pre-treatment.
AE Fatigue (grade 1) for SITE002-0071 has onset 2025-12-08, 1 d before first dose on 2025-12-09. Confirm onset date or record as pre-treatment.
AE Diarrhoea (grade 2) for SITE014-0280 has onset 2026-08-19, 1 d before first dose on 2026-08-20. Confirm onset date or record as pre-treatment.
AE Asthenia (grade 1) for SITE012-0100 has onset 2026-01-11, 1 d before first dose on 2026-01-12. Confirm onset date or record as pre-treatment.
AE Adverse event (serious) for SITE001-0066 (onset undated) is flagged serious but no seriousness criterion (death, life-threatening, hospitalization, disability, congenital anomaly, other) is recorded.
2 adverse event records for SITE012-0277 share preferred term Asthenia and onset 2026-08-17. Duplicate entry; the first record (entered 2026-08-17) is kept.
Auto-closed by AE-007 (duplicate AE record): first of 2 identical records kept; the 1 later copy flagged for the site to delete or differentiate.
2 adverse event records for SITE004-0041 share preferred term Anaemia and onset 2025-12-04. Duplicate entry; the first record (entered 2025-12-04) is kept.
Auto-closed by AE-007 (duplicate AE record): first of 2 identical records kept; the 1 later copy flagged for the site to delete or differentiate.
EDC value 113 differs from the EHR: 131 mmHg (Observation/vs-7d2882169021-8480-6-20251011, 2025-10-11; EHR stated 131 mm[Hg]). Confirm against source and correct or explain.
Temperature 3.7 C is below the plausible minimum 34 C.
Clinical data management — EDC queries 88
EDC value 120 differs from the EHR: 102 mmHg (Observation/vs-b9c3c2577d57-8480-6-20120226, 2012-02-26; EHR stated 102 mm[Hg]). Confirm against source and correct or explain.
Temperature 3.7 C is below the plausible minimum 34 C.
AE Neutropenia (grade 4) for P2B-132 (onset 2013-08-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-034 (onset 2012-12-03) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-050 (onset 2012-12-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-126 (onset 2013-07-19) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-082 (onset 2013-03-25) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-011 (onset 2012-09-13) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Febrile neutropenia (grade 4) for P2B-033 (onset 2012-11-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-033 (onset 2012-11-04) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-003 (onset 2012-04-03) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-104 (onset 2013-08-12) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-020 (onset 2012-10-17) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Thrombocytopenia (grade 4) for P2B-135 (onset 2013-08-15) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-019 (onset 2012-07-31) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Anaemia (grade 4) for P2B-001 (onset 2012-03-28) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Neutropenia (grade 4) for P2B-024 (onset 2012-09-19) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
AE Thrombocytopenia (grade 4) for P2B-081 (onset 2013-03-22) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-008 occurred on 2012-10-01, 12 d late against planned day 106 (2012-09-19 ± 3 d, anchored on first dose 2012-06-06). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-003 occurred on 2012-06-26, 6 d late against planned day 85 (2012-06-20 ± 3 d, anchored on first dose 2012-03-28). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-059 occurred on 2013-03-04, 13 d late against planned day 64 (2013-02-19 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-018 occurred on 2012-11-18, 4 d late against planned day 106 (2012-11-14 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-031 occurred on 2012-12-21, 9 d late against planned day 85 (2012-12-12 ± 3 d, anchored on first dose 2012-09-19). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-005 occurred on 2012-08-07, 6 d late against planned day 85 (2012-08-01 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-043 occurred on 2013-01-19, 13 d late against planned day 64 (2013-01-06 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-126 occurred on 2013-09-12, 4 d late against planned day 64 (2013-09-08 ± 3 d, anchored on first dose 2013-07-07). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-087 occurred on 2013-04-25, 9 d late against planned day 22 (2013-04-16 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-062 occurred on 2013-04-13, 10 d late against planned day 85 (2013-04-03 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-003 occurred on 2012-07-17, 6 d late against planned day 106 (2012-07-11 ± 3 d, anchored on first dose 2012-03-28). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-005 occurred on 2012-07-16, 5 d late against planned day 64 (2012-07-11 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-073 occurred on 2013-06-15, 9 d late against planned day 106 (2013-06-06 ± 3 d, anchored on first dose 2013-02-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-077 occurred on 2013-05-17, 5 d late against planned day 64 (2013-05-12 ± 3 d, anchored on first dose 2013-03-10). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-062 occurred on 2013-03-03, 11 d late against planned day 43 (2013-02-20 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-105 occurred on 2013-08-16, 7 d late against planned day 85 (2013-08-09 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-067 occurred on 2013-03-27, 5 d late against planned day 64 (2013-03-22 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-059 occurred on 2013-03-24, 12 d late against planned day 85 (2013-03-12 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-132 occurred on 2013-09-08, 4 d late against planned day 43 (2013-09-04 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-010 occurred on 2012-09-21, 8 d late against planned day 85 (2012-09-13 ± 3 d, anchored on first dose 2012-06-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-043 occurred on 2012-11-30, 5 d late against planned day 22 (2012-11-25 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-134 occurred on 2013-11-08, 5 d late against planned day 106 (2013-11-03 ± 3 d, anchored on first dose 2013-07-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-043 occurred on 2013-03-01, 12 d late against planned day 106 (2013-02-17 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-133 occurred on 2013-11-13, 9 d late against planned day 106 (2013-11-04 ± 3 d, anchored on first dose 2013-07-22). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-008 occurred on 2012-09-11, 13 d late against planned day 85 (2012-08-29 ± 3 d, anchored on first dose 2012-06-06). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-040 occurred on 2013-01-08, 9 d late against planned day 64 (2012-12-30 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-033 occurred on 2012-10-29, 12 d late against planned day 22 (2012-10-17 ± 3 d, anchored on first dose 2012-09-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-126 occurred on 2013-08-23, 5 d late against planned day 43 (2013-08-18 ± 3 d, anchored on first dose 2013-07-07). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-067 occurred on 2013-03-06, 5 d late against planned day 43 (2013-03-01 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-059 occurred on 2013-04-14, 12 d late against planned day 106 (2013-04-02 ± 3 d, anchored on first dose 2012-12-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-043 occurred on 2013-02-08, 12 d late against planned day 85 (2013-01-27 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-134 occurred on 2013-10-17, 4 d late against planned day 85 (2013-10-13 ± 3 d, anchored on first dose 2013-07-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-130 occurred on 2013-11-17, 9 d late against planned day 106 (2013-11-08 ± 3 d, anchored on first dose 2013-07-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-036 occurred on 2013-01-27, 10 d late against planned day 106 (2013-01-17 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-087 occurred on 2013-06-08, 11 d late against planned day 64 (2013-05-28 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-125 occurred on 2013-09-03, 13 d late against planned day 43 (2013-08-21 ± 3 d, anchored on first dose 2013-07-10). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-033 occurred on 2012-11-19, 12 d late against planned day 43 (2012-11-07 ± 3 d, anchored on first dose 2012-09-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-062 occurred on 2013-05-04, 10 d late against planned day 106 (2013-04-24 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-133 occurred on 2013-10-24, 10 d late against planned day 85 (2013-10-14 ± 3 d, anchored on first dose 2013-07-22). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-067 occurred on 2013-05-09, 6 d late against planned day 106 (2013-05-03 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-073 occurred on 2013-05-26, 10 d late against planned day 85 (2013-05-16 ± 3 d, anchored on first dose 2013-02-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-132 occurred on 2013-08-18, 4 d late against planned day 22 (2013-08-14 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-087 occurred on 2013-07-30, 21 d late against planned day 106 (2013-07-09 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-067 occurred on 2013-04-17, 5 d late against planned day 85 (2013-04-12 ± 3 d, anchored on first dose 2013-01-18). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-040 occurred on 2013-02-26, 16 d late against planned day 106 (2013-02-10 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-105 occurred on 2013-07-27, 8 d late against planned day 64 (2013-07-19 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-036 occurred on 2012-11-25, 10 d late against planned day 43 (2012-11-15 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-125 occurred on 2013-10-01, 20 d late against planned day 64 (2013-09-11 ± 3 d, anchored on first dose 2013-07-10). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-018 occurred on 2012-10-08, 5 d late against planned day 64 (2012-10-03 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-062 occurred on 2013-02-11, 12 d late against planned day 22 (2013-01-30 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-018 occurred on 2012-10-29, 5 d late against planned day 85 (2012-10-24 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-036 occurred on 2013-01-07, 11 d late against planned day 85 (2012-12-27 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-040 occurred on 2013-02-04, 15 d late against planned day 85 (2013-01-20 ± 3 d, anchored on first dose 2012-10-28). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-062 occurred on 2013-03-23, 10 d late against planned day 64 (2013-03-13 ± 3 d, anchored on first dose 2013-01-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-031 occurred on 2013-01-11, 9 d late against planned day 106 (2013-01-02 ± 3 d, anchored on first dose 2012-09-19). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-078 occurred on 2013-04-27, 10 d late against planned day 43 (2013-04-17 ± 3 d, anchored on first dose 2013-03-06). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-130 occurred on 2013-10-26, 8 d late against planned day 85 (2013-10-18 ± 3 d, anchored on first dose 2013-07-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-043 occurred on 2012-12-22, 6 d late against planned day 43 (2012-12-16 ± 3 d, anchored on first dose 2012-11-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-105 occurred on 2013-09-11, 12 d late against planned day 106 (2013-08-30 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-130 occurred on 2013-10-05, 8 d late against planned day 64 (2013-09-27 ± 3 d, anchored on first dose 2013-07-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-036 occurred on 2012-12-16, 10 d late against planned day 64 (2012-12-06 ± 3 d, anchored on first dose 2012-10-04). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-018 occurred on 2012-09-17, 5 d late against planned day 43 (2012-09-12 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-087 occurred on 2013-05-17, 10 d late against planned day 43 (2013-05-07 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-078 occurred on 2013-04-01, 5 d late against planned day 22 (2013-03-27 ± 3 d, anchored on first dose 2013-03-06). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-087 occurred on 2013-07-10, 22 d late against planned day 85 (2013-06-18 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-010 occurred on 2012-10-13, 9 d late against planned day 106 (2012-10-04 ± 3 d, anchored on first dose 2012-06-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-005 occurred on 2012-08-29, 7 d late against planned day 106 (2012-08-22 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-005 occurred on 2012-06-24, 4 d late against planned day 43 (2012-06-20 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-133 occurred on 2013-10-04, 11 d late against planned day 64 (2013-09-23 ± 3 d, anchored on first dose 2013-07-22). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-005 occurred on 2012-06-04, 5 d late against planned day 22 (2012-05-30 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.