SITE015-0086

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 2022-05-28

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 80); relationship: Y

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 146); relationship: Y

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-11-12 (study day 150); relationship: N

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 247); relationship: N

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-18 (study day 276); relationship: N

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 359); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 370); relationship: not assessed

Data queries

No data queries.