SITE010-0279

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 2023-01-23

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 70); relationship: Y

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-24 (study day 317); relationship: Y

moderate assessed

Grade 2 Alopecia — outcome: UNKNOWN; onset 2024-01-17 (study day 341); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-25 (study day 349); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-10 (study day 365); relationship: N

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-25 (study day 440); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-27 (study day 442); relationship: Y

severe assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-29 (study day 444); relationship: not assessed

Data queries

No data queries.