SITE007-0283

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
SITE007 (JPN) · Dr. Dubois
consented 2023-02-01

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 56); relationship: not assessed

moderate assessed

Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-05-16 (study day 91); relationship: Y

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-24 (study day 222); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 306); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 416); relationship: not assessed

severe assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-23 (study day 434); relationship: not assessed

severe serious assessed

Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-07-15 (study day 517); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-08-20 (study day 553); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-14 (study day 608); relationship: N

Data queries

No data queries.