SITE001-0029

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SITE001-0029

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
SITE001 (USA) · Dr. Reyes
consented 2025-09-21

completed

AEs

8

Serious

0

Dropout signal

–

Adverse events

8

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-03 (study day 59); relationship: not assessed

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 53); relationship: NOT RELATED

mild assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 46); relationship: not assessed

moderate assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-10 (study day 35); relationship: not assessed

mild assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-26 (study day 21); relationship: RELATED

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-25 (study day 20); relationship: not assessed

moderate assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-24 (study day 19); relationship: not assessed

mild assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-08 (study day 3); relationship: not assessed

moderate assessed

Data queries

1

EDC value 113 differs from the EHR: 131 mmHg (Observation/vs-7d2882169021-8480-6-20251011, 2025-10-11; EHR stated 131 mm[Hg]). Confirm against source and correct or explain.

F.VS.SYSBP (Systolic blood pressure) open