SITE006-0059

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
SITE006 (GBR) · Dr. Rossi
consented 2022-04-28

AEs

Serious

Dropout signal

–

Adverse events

severe serious assessed

Grade 4 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2022-07-01 (study day 47); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 60); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-26 (study day 72); relationship: N

mild assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-08-21 (study day 98); relationship: N

severe assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-27 (study day 135); relationship: not assessed

moderate assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 154); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 173); relationship: Y

severe assessed

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-12 (study day 211); relationship: not assessed

severe assessed

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-12-28 (study day 227); relationship: Y

Data queries

No data queries.