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← SITE009 (AUS)

SITE009-0415

completed
Study: 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 · Site: SITE009 (AUS) (Dr. Novak) · consented 2023-07-30
Adverse events
8
Serious AEs
1
Open data queries
0
Luna dropout signal
–

Adverse events

mild assessed 2026-08-18

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

severe serious assessed 2026-08-18

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

mild assessed 2026-08-18

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

mild assessed 2026-08-18

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

mild assessed 2026-08-18

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

moderate assessed 2026-08-18

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

moderate assessed 2026-08-18

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

mild assessed 2026-08-18

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

Data queries

No data queries.

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