SITE011-0297

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 2023-02-21

Adverse events

Serious AEs

Open data queries

Luna dropout signal

–

Adverse events

moderate assessed 2026-08-18

Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 32); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-13 (study day 73); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 88); relationship: not assessed

severe assessed 2026-08-18

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 108); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 269); relationship: N

moderate assessed 2026-08-18

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 380); relationship: Y

severe serious assessed 2026-08-18

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-07 (study day 433); relationship: not assessed; serious criteria: hospitalization

moderate assessed 2026-08-18

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-26 (study day 544); relationship: N

moderate assessed 2026-08-18

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-09-10 (study day 559); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-29 (study day 639); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-19 (study day 659); relationship: N

Data queries

No data queries.

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