SITE003-0406

withdrawn

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
SITE003 (CAN) · Dr. Okafor
consented 2023-07-07

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-29 (study day 2); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-05 (study day 9); relationship: not assessed

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-09-02 (study day 37); relationship: not assessed

severe serious assessed

Grade 4 Vomiting — outcome: UNKNOWN; onset 2023-10-30 (study day 95); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 148); relationship: N

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 152); relationship: not assessed

severe assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-01-29 (study day 186); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-27 (study day 244); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-04 (study day 252); relationship: not assessed

Data queries

No data queries.