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SITE011-0281

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 2023-01-30

AEs
8
Serious
1
Dropout signal
–

Adverse events

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 5); relationship: not assessed

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-04-30 (study day 77); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 86); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 86); relationship: N

severe serious assessed

Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-28 (study day 136); relationship: N; serious criteria: hospitalization

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-07-11 (study day 149); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-17 (study day 155); relationship: Y

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 313); relationship: not assessed

Data queries

No data queries.