SITE013-0232

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
SITE013 (USA) · Dr. Clarke

consented 2022-12-01

AEs
11
Serious
1
Dropout signal

Adverse events

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-19 (study day 9); relationship: not assessed

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-12-22 (study day 12); relationship: Y

severe serious assessed

Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-14 (study day 35); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 43); relationship: Y

moderate assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 51); relationship: not assessed

moderate assessed

Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 86); relationship: not assessed

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-03-07 (study day 87); relationship: not assessed

moderate assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-03-13 (study day 93); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-25 (study day 105); relationship: not assessed

mild assessed

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 183); relationship: Y

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 193); relationship: not assessed

Data queries

No data queries.