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SITE014-0313

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
SITE014 (NLD) · Dr. Moreau
consented 2023-03-11

AEs
10
Serious
2
Dropout signal
–

Adverse events

severe serious assessed

Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 31); relationship: not assessed; serious criteria: hospitalization

severe assessed

Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-05-14 (study day 57); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-08-24 (study day 159); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-09-04 (study day 170); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 172); relationship: not assessed

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 210); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 284); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-19 (study day 398); relationship: Y

mild assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-20 (study day 429); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-23 (study day 432); relationship: not assessed

Data queries

No data queries.