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SITE006-0421

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
SITE006 (GBR) · Dr. Rossi
consented 2023-08-05

AEs
8
Serious
2
Dropout signal
–

Adverse events

severe serious assessed

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-21 (study day 2); relationship: Y; serious criteria: life-threatening

severe serious assessed

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 22); relationship: N; serious criteria: hospitalization

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-09-10 (study day 22); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 73); relationship: N

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-17 (study day 90); relationship: N

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-19 (study day 122); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-29 (study day 132); relationship: N

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 133); relationship: not assessed

Data queries

No data queries.