SITE004-0031

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SITE004-0031

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
SITE004 (DEU) · Dr. Tanaka
consented 2025-10-01

completed

AEs

8

Serious

1

Dropout signal

–

Adverse events

8

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-08-13 (study day 129); relationship: RELATED

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-06-09 (study day 64); relationship: NOT RELATED

mild assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 42); relationship: not assessed

moderate assessed

Grade 2 Peripheral neuropathy — outcome: UNKNOWN; onset 2022-05-09 (study day 33); relationship: NOT RELATED

moderate assessed

Grade 1 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: not assessed

mild assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: NOT RELATED; serious criteria: life-threatening

severe serious assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 6); relationship: NOT RELATED

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-09 (study day 3); relationship: NOT RELATED

moderate assessed

Data queries

0

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