SITE009-0351

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
SITE009 (AUS) · Dr. Novak

consented 2023-04-14

AEs
8
Serious
1
Dropout signal

Adverse events

severe assessed

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 20); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 76); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-15 (study day 109); relationship: N

severe serious assessed

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 242); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-14 (study day 321); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-25 (study day 424); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-08-19 (study day 479); relationship: not assessed

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-08-27 (study day 487); relationship: N

Data queries

No data queries.