SITE005-0327

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 2023-03-28

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-12 (study day 5); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-27 (study day 20); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-15 (study day 161); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 234); relationship: N

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-24 (study day 383); relationship: not assessed

severe assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-06-07 (study day 427); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-06-20 (study day 440); relationship: not assessed

severe assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-31 (study day 481); relationship: Y

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-09-02 (study day 514); relationship: N

Data queries

No data queries.