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SITE011-0107

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
SITE011 (ITA) · Dr. Jansen
consented 2022-07-04

AEs
8
Serious
3
Dropout signal
–

Adverse events

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 11); relationship: Y

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-29 (study day 12); relationship: not assessed; serious criteria: hospitalization

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-20 (study day 34); relationship: N; serious criteria: life-threatening

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 36); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 50); relationship: N

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 59); relationship: Y; serious criteria: life-threatening

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: not assessed

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: N

Data queries

No data queries.