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SITE009-0353

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 2023-04-25

AEs
6
Serious
2
Dropout signal
–

Adverse events

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 39); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-24 (study day 54); relationship: not assessed

severe serious assessed

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 174); relationship: Y; serious criteria: hospitalization

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 221); relationship: N

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-05-17 (study day 382); relationship: N

severe serious assessed

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-18 (study day 444); relationship: not assessed; serious criteria: hospitalization

Data queries

No data queries.