SITE005-0273

completed

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 2023-01-21

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-20 (study day 21); relationship: Y

severe serious assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 30); relationship: not assessed; serious criteria: hospitalization

severe assessed

Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 36); relationship: N

severe assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-08 (study day 37); relationship: not assessed

severe assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-11 (study day 40); relationship: Y

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 78); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 78); relationship: not assessed

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 93); relationship: N

Data queries

No data queries.