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SITE009-0415

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
SITE009 (AUS) · Dr. Novak
consented 2023-07-30

AEs
8
Serious
1
Dropout signal
–

Adverse events

mild assessed

Grade 1 Hyperthyroidism — outcome: RECOVERED/RESOLVED; onset 2023-09-23 (study day 48); relationship: not assessed

severe serious assessed

Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-14 (study day 69); relationship: Y; serious criteria: life-threatening

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-20 (study day 75); relationship: not assessed

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-25 (study day 80); relationship: not assessed

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-19 (study day 105); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-01-22 (study day 169); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 202); relationship: N

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-16 (study day 254); relationship: N

Data queries

No data queries.