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SITE005-0047

withdrawn

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 2022-04-20

AEs
8
Serious
3
Dropout signal
–

Adverse events

severe serious assessed

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 33); relationship: N; serious criteria: hospitalization

severe serious assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-05 (study day 62); relationship: N; serious criteria: hospitalization

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 289); relationship: N

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 403); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-08 (study day 522); relationship: N

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-27 (study day 541); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 569); relationship: N

severe serious assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 592); relationship: not assessed; serious criteria: hospitalization

Data queries

No data queries.