SITE004-0229

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 2022-11-22

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 33); relationship: N

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 33); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 52); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 56); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 93); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2023-04-15 (study day 132); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 134); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-20 (study day 137); relationship: N

severe serious assessed

Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-05 (study day 213); relationship: not assessed; serious criteria: life-threatening

Data queries

No data queries.