SITE005-0287

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
SITE005 (FRA) · Dr. Muller
consented 2023-01-27

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 10); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-04 (study day 47); relationship: not assessed

severe serious assessed

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 88); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 93); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-26 (study day 160); relationship: N; serious criteria: hospitalization

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-01 (study day 227); relationship: not assessed

severe serious assessed

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-13 (study day 270); relationship: Y; serious criteria: life-threatening

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-11-27 (study day 284); relationship: not assessed

Data queries

No data queries.