SITE012-0006

completed

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 2022-02-22

AEs
9
Serious
2
Dropout signal

Adverse events

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-03-17 (study day 13); relationship: not assessed

mild assessed

Grade 1 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-07 (study day 34); relationship: not assessed

severe serious assessed

Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 39); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-15 (study day 72); relationship: not assessed

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-07-14 (study day 132); relationship: N

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-08-05 (study day 154); relationship: not assessed

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-16 (study day 469); relationship: not assessed

severe assessed

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-02-19 (study day 717); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 761); relationship: not assessed; serious criteria: hospitalization

Data queries

No data queries.