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← SITE007 (JPN)

SITE007-0378

withdrawn
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: SITE007 (JPN) (Dr. Dubois) · consented 2023-05-13
Adverse events
8
Serious AEs
2
Open data queries
0
Luna dropout signal
–

Adverse events

mild assessed 2026-08-18

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 11); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 20); relationship: Y

severe assessed 2026-08-18

Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 29); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 37); relationship: not assessed

severe serious assessed 2026-08-18

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 98); relationship: not assessed; serious criteria: life-threatening

mild assessed 2026-08-18

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 104); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 129); relationship: not assessed

severe serious assessed 2026-08-18

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 139); relationship: Y; serious criteria: hospitalization

Data queries

No data queries.

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