GalenOps Field · GalenOps

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious under_review

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)

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization