SITE010-0449

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 2023-09-16

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-01-19 (study day 115); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-12 (study day 168); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-04 (study day 221); relationship: N

mild assessed

Grade 1 Nausea — outcome: UNKNOWN; onset 2024-09-21 (study day 361); relationship: not assessed

severe serious assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-10-03 (study day 373); relationship: Y; serious criteria: hospitalization

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-10-25 (study day 395); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-11-23 (study day 424); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-13 (study day 444); relationship: not assessed

Data queries

No data queries.