SITE007-0122

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
SITE007 (JPN) · Dr. Dubois
consented 2022-07-16

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-11-25 (study day 115); relationship: not assessed

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-01-16 (study day 167); relationship: N

severe assessed

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 168); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-01-20 (study day 171); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 182); relationship: not assessed

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-05-25 (study day 296); relationship: not assessed

severe serious assessed

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 539); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-09-15 (study day 775); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-26 (study day 816); relationship: N

Data queries

No data queries.