SITE011-0310

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
SITE011 (ITA) · Dr. Jansen
consented 2023-03-02

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-11 (study day 58); relationship: not assessed

severe serious assessed

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-13 (study day 91); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 100); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-08 (study day 239); relationship: N

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-13 (study day 274); relationship: not assessed

severe assessed

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 288); relationship: N

Data queries

No data queries.