SITE015-0443

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 2023-09-08

AEs
9
Serious
1
Dropout signal

Adverse events

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-09-28 (study day 7); relationship: not assessed

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-03 (study day 12); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-20 (study day 29); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-11-13 (study day 53); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 74); relationship: not assessed

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 74); relationship: Y; serious criteria: life-threatening

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-12-10 (study day 80); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-12 (study day 113); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-01-24 (study day 125); relationship: not assessed

Data queries

No data queries.