SITE012-0320

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
SITE012 (BRA) · Dr. Kowalski
consented 2023-03-18

AEs

Serious

Dropout signal

–

Adverse events

severe assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 51); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 56); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-14 (study day 290); relationship: Y

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 299); relationship: not assessed

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-02-06 (study day 313); relationship: not assessed

moderate assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 331); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 367); relationship: N

severe serious assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-06 (study day 373); relationship: N; serious criteria: hospitalization

Data queries

No data queries.