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SITE005-0342

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
SITE005 (FRA) · Dr. Muller
consented 2023-04-02

AEs
7
Serious
1
Dropout signal
–

Adverse events

severe assessed

Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 39); relationship: not assessed

severe serious assessed

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-07-13 (study day 85); relationship: Y; serious criteria: hospitalization

severe assessed

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-02-03 (study day 290); relationship: not assessed

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-07 (study day 323); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-04-05 (study day 352); relationship: not assessed

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-08-05 (study day 474); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-10-15 (study day 545); relationship: not assessed

Data queries

No data queries.