SITE013-0348

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
SITE013 (USA) · Dr. Clarke
consented 2023-04-11

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-10 (study day 104); relationship: N

moderate assessed

Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 110); relationship: not assessed

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-31 (study day 186); relationship: not assessed

severe assessed

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 207); relationship: Y

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-03-03 (study day 310); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-21 (study day 328); relationship: N

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-06 (study day 435); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-07-07 (study day 436); relationship: Y

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-08-18 (study day 478); relationship: not assessed

Data queries

No data queries.