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SITE006-0024

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 2022-03-22

AEs
7
Serious
3
Dropout signal
–

Adverse events

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-03-31 (study day 3); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-05-01 (study day 34); relationship: N

severe serious assessed

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-07 (study day 40); relationship: N; serious criteria: hospitalization

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-11 (study day 44); relationship: not assessed

severe serious assessed

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-22 (study day 55); relationship: Y; serious criteria: hospitalization

severe serious assessed

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 60); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-15 (study day 79); relationship: not assessed

Data queries

No data queries.