SITE001-0092

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
SITE001 (USA) · Dr. Reyes
consented 2022-06-15

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-07-13 (study day 15); relationship: Y

mild assessed

Grade 1 Neutropenia — outcome: UNKNOWN; onset 2022-07-15 (study day 17); relationship: not assessed

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 57); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-02 (study day 66); relationship: not assessed

moderate assessed

Grade 2 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-09-02 (study day 66); relationship: Y

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 81); relationship: N

severe serious assessed

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 138); relationship: not assessed

Data queries

No data queries.