SITE010-0205

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
SITE010 (ESP) · Dr. Silva
consented 2022-10-28

AEs

Serious

Dropout signal

–

Adverse events

severe assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-28 (study day 22); relationship: N

moderate assessed

Grade 2 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 88); relationship: not assessed

severe serious assessed

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 195); relationship: N; serious criteria: hospitalization

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 268); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-13 (study day 402); relationship: N

severe assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 487); relationship: Y

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-05-02 (study day 543); relationship: Y

Data queries

No data queries.