SITE004-0363

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 2023-04-29

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 45); relationship: not assessed

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-01-08 (study day 238); relationship: N

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-15 (study day 397); relationship: not assessed

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-07-17 (study day 429); relationship: not assessed

severe serious reported

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-12 (study day 516); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-11-29 (study day 564); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2025-01-01 (study day 597); relationship: not assessed

Data queries

No data queries.