SITE008-0247

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
SITE008 (KOR) · Dr. Kim

consented 2022-12-13

AEs
11
Serious
2
Dropout signal

Adverse events

severe serious assessed

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 13); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-07 (study day 44); relationship: not assessed

mild assessed

Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-03-10 (study day 75); relationship: not assessed

moderate assessed

Grade 2 Alanine aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-03-22 (study day 87); relationship: Y

severe assessed

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-04-03 (study day 99); relationship: N

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-15 (study day 172); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-06-26 (study day 183); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-16 (study day 265); relationship: not assessed

severe assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-09-25 (study day 274); relationship: not assessed

severe serious assessed

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-18 (study day 328); relationship: N; serious criteria: hospitalization

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-11-30 (study day 340); relationship: Y

Data queries

No data queries.