SITE003-0291

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
SITE003 (CAN) · Dr. Okafor
consented 2023-02-10

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-04-03 (study day 40); relationship: Y

mild assessed

Grade 1 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-04-24 (study day 61); relationship: not assessed

severe assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 145); relationship: Y

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 159); relationship: N

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-11-26 (study day 277); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-03 (study day 315); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-11 (study day 354); relationship: not assessed

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 406); relationship: N

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 507); relationship: not assessed

severe serious assessed

Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-09-18 (study day 574); relationship: not assessed; serious criteria: life-threatening

Data queries

No data queries.