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SITE012-0195

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 2022-10-12

AEs
10
Serious
1
Dropout signal
–

Adverse events

severe serious assessed

Grade 3 Asthenia — outcome: UNKNOWN; onset 2022-12-31 (study day 60); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-21 (study day 81); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-17 (study day 167); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 228); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-11 (study day 405); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-31 (study day 425); relationship: N

severe assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-02-13 (study day 469); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-01 (study day 486); relationship: N

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-03-08 (study day 493); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-30 (study day 515); relationship: not assessed

Data queries

No data queries.