SITE010-0248

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
SITE010 (ESP) · Dr. Silva
consented 2022-12-09

AEs

Serious

Dropout signal

–

Adverse events

severe serious assessed

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-02 (study day 8); relationship: Y; serious criteria: life-threatening

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 15); relationship: N

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-10 (study day 16); relationship: N

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 35); relationship: not assessed

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 41); relationship: Y

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-15 (study day 52); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: UNKNOWN; onset 2023-03-05 (study day 70); relationship: not assessed

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-03-28 (study day 93); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-30 (study day 95); relationship: not assessed

Data queries

No data queries.