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SITE009-0089

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 2022-06-16

AEs
8
Serious
2
Dropout signal
–

Adverse events

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 162); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-27 (study day 216); relationship: N

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-27 (study day 367); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 401); relationship: Y

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 645); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-05-24 (study day 699); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-06 (study day 742); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Thrombocytopenia — outcome: UNKNOWN; onset 2024-07-07 (study day 743); relationship: Y

Data queries

No data queries.