SITE002-0025

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
SITE002 (USA) · Dr. Nolan
consented 2022-03-18

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-07 (study day 8); relationship: not assessed

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-26 (study day 57); relationship: N

severe serious assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 119); relationship: N; serious criteria: hospitalization

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-10 (study day 133); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-15 (study day 138); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 266); relationship: Y

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 324); relationship: N

moderate assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 345); relationship: Y

Data queries

No data queries.