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SITE004-0360

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
SITE004 (DEU) · Dr. Tanaka
consented 2023-04-27

AEs
7
Serious
1
Dropout signal
–

Adverse events

severe assessed

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-05 (study day 56); relationship: N

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-08-13 (study day 95); relationship: not assessed

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 258); relationship: not assessed

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-07-24 (study day 441); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-08-06 (study day 454); relationship: Y

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-12 (study day 460); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-08-18 (study day 466); relationship: not assessed

Data queries

No data queries.