SITE004-0194

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
SITE004 (DEU) · Dr. Tanaka
consented 2022-10-15

AEs

Serious

Dropout signal

–

Adverse events

severe serious assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 3); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 7); relationship: Y

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-15 (study day 134); relationship: not assessed

severe assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 152); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 315); relationship: not assessed

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 404); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-27 (study day 634); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-09-25 (study day 694); relationship: not assessed

Data queries

No data queries.