SITE015-0198

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
SITE015 (POL) · Dr. Ito
consented 2022-10-15

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-11-30 (study day 28); relationship: Y

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 56); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 68); relationship: N

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 120); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-05 (study day 123); relationship: not assessed

mild assessed

Grade 1 Fatigue — outcome: UNKNOWN; onset 2023-03-27 (study day 145); relationship: Y

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-06-18 (study day 228); relationship: Y

severe serious assessed

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-30 (study day 240); relationship: not assessed; serious criteria: hospitalization

Data queries

No data queries.