SITE004-0345

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 2023-04-04

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 41); relationship: Y

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-08-23 (study day 123); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 178); relationship: N

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 291); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-01 (study day 375); relationship: not assessed

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-05-04 (study day 378); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-12-05 (study day 593); relationship: not assessed

severe serious reported

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2025-01-14 (study day 633); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2025-01-16 (study day 635); relationship: not assessed

Data queries

No data queries.