SITE005-0365

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 2023-05-02

AEs
9
Serious
1
Dropout signal

Adverse events

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 34); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: UNKNOWN; onset 2023-06-25 (study day 41); relationship: not assessed

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-01 (study day 109); relationship: not assessed

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-04 (study day 142); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 169); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 186); relationship: N

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-02-21 (study day 282); relationship: not assessed

severe serious assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-25 (study day 286); relationship: N; serious criteria: hospitalization

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 320); relationship: N

Data queries

No data queries.