SITE001-0034

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 2022-04-02

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-06-28 (study day 76); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-20 (study day 160); relationship: N

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-13 (study day 183); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-07-31 (study day 474); relationship: Y

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-08-01 (study day 475); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-15 (study day 489); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-12-05 (study day 601); relationship: Y

Data queries

No data queries.