SITE007-0231

withdrawn

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
SITE007 (JPN) · Dr. Dubois
consented 2022-11-18

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 50); relationship: N

mild assessed

Grade 1 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 57); relationship: not assessed

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 72); relationship: N

severe serious assessed

Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 96); relationship: not assessed

mild assessed

Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 96); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 105); relationship: not assessed

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-05-01 (study day 145); relationship: not assessed

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-05-15 (study day 159); relationship: N

severe assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-05-31 (study day 175); relationship: Y

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-22 (study day 197); relationship: not assessed

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 212); relationship: N

Data queries

No data queries.