SITE008-0450

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: SITE008 (KOR) (Dr. Kim) · consented 2023-09-17

Adverse events

Serious AEs

Open data queries

Luna dropout signal

–

Adverse events

mild assessed 2026-08-18

Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-11-02 (study day 36); relationship: Y

mild assessed 2026-08-18

Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-11-16 (study day 50); relationship: not assessed

severe assessed 2026-08-18

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-08 (study day 72); relationship: not assessed

moderate assessed 2026-08-18

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-02-08 (study day 134); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-03-16 (study day 171); relationship: not assessed

mild assessed 2026-08-18

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-04-11 (study day 197); relationship: not assessed

severe serious assessed 2026-08-18

Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2024-05-07 (study day 223); relationship: not assessed; serious criteria: life-threatening

moderate assessed 2026-08-18

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-07-20 (study day 297); relationship: Y

moderate assessed 2026-08-18

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-09-28 (study day 367); relationship: not assessed

Data queries

No data queries.

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