SITE005-0219

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 2022-11-15

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Vomiting — outcome: UNKNOWN; onset 2022-12-18 (study day 22); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 101); relationship: not assessed

severe serious assessed

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 216); relationship: not assessed; serious criteria: hospitalization

severe assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-09 (study day 225); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-23 (study day 239); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 280); relationship: N

severe serious assessed

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 400); relationship: not assessed; serious criteria: hospitalization

Data queries

No data queries.