SITE005-0396

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 2023-07-02

AEs
7
Serious
1
Dropout signal

Adverse events

moderate assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 25); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-08-11 (study day 25); relationship: N; serious criteria: hospitalization

moderate assessed

Grade 2 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-08-14 (study day 28); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 30); relationship: N

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-08-27 (study day 41); relationship: N

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-08-29 (study day 43); relationship: N

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-21 (study day 66); relationship: not assessed

Data queries

No data queries.