SITE005-0014

SITE005 (FRA) › SITE005-0014

SITE005-0014

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer · Phase III
SITE005 (FRA) · Dr. Muller
consented 2025-09-07

withdrawn

AEs

8

Serious

2

Dropout signal

–

Adverse events

8

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-03 (study day 108); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 103); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 103); relationship: NOT RELATED

mild assessed

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-05 (study day 80); relationship: not assessed; serious criteria: life-threatening

severe serious assessed

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 72); relationship: NOT RELATED; serious criteria: life-threatening

severe serious assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-11 (study day 55); relationship: NOT RELATED

mild assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-05-06 (study day 50); relationship: not assessed

moderate assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-05-05 (study day 49); relationship: not assessed

mild assessed

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