SITE012-0100

SITE012 (BRA) › SITE012-0100

SITE012-0100

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
SITE012 (BRA) · Dr. Kowalski
consented 2025-12-25

completed

AEs

5

Serious

1

Dropout signal

–

Adverse events

5

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-08-01 (study day 27); relationship: not assessed

severe assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 22); relationship: not assessed; serious criteria: hospitalization

severe serious assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-07-22 (study day 17); relationship: NOT RELATED

mild assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 9); relationship: not assessed

moderate assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-07-07 (study day 2); relationship: not assessed

mild assessed

Data queries

1

AE Asthenia (grade 1) for SITE012-0100 has onset 2026-01-11, 1 d before first dose on 2026-01-12. Confirm onset date or record as pre-treatment.

onset_on[Asthenia 2026-01-11] open