SITE001-0165

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
SITE001 (USA) · Dr. Reyes
consented 2022-09-10

AEs

Serious

Dropout signal

–

Adverse events

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 2); relationship: N

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 2); relationship: not assessed

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 4); relationship: Y

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-09-29 (study day 4); relationship: N

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 6); relationship: not assessed

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 9); relationship: not assessed

Data queries

No data queries.