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SITE011-0332

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 2023-03-31

AEs
10
Serious
1
Dropout signal
–

Adverse events

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 9); relationship: N

severe serious assessed

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 19); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-05-03 (study day 21); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-19 (study day 37); relationship: N

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-21 (study day 39); relationship: N

mild assessed

Grade 1 Stomatitis — outcome: UNKNOWN; onset 2023-05-25 (study day 43); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 49); relationship: Y

mild assessed

Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-06-10 (study day 59); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-16 (study day 65); relationship: N

severe assessed

Grade 3 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-06-19 (study day 68); relationship: not assessed

Data queries

No data queries.