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← SITE011 (ITA)

SITE011-0175

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: SITE011 (ITA) (Dr. Jansen) · consented 2022-09-18
Adverse events
12
Serious AEs
1
Open data queries
0
Luna dropout signal
–

Adverse events

moderate assessed 2026-08-18

Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 42); relationship: Y

moderate assessed 2026-08-18

Grade 2 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 46); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2022-12-18 (study day 72); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 131); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 236); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-07-03 (study day 269); relationship: not assessed

severe serious assessed 2026-08-18

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 363); relationship: N; serious criteria: hospitalization

moderate assessed 2026-08-18

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-04 (study day 423); relationship: Y

mild assessed 2026-08-18

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-11 (study day 521); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-08-05 (study day 668); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-09-13 (study day 707); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-20 (study day 744); relationship: not assessed

Data queries

No data queries.

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