SITE004-0088

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 2022-06-08

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-08 (study day 15); relationship: not assessed

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-07-19 (study day 26); relationship: not assessed

severe serious assessed

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening

severe assessed

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 34); relationship: N

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-25 (study day 185); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 342); relationship: not assessed

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-12 (study day 354); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 371); relationship: N

severe assessed

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-07-25 (study day 397); relationship: not assessed

Data queries

No data queries.