SITE003-0403

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
SITE003 (CAN) · Dr. Okafor

consented 2023-07-03

AEs
10
Serious
1
Dropout signal

Adverse events

mild assessed

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-08-16 (study day 24); relationship: not assessed

mild assessed

Grade 1 Aspartate aminotransferase increased — outcome: RECOVERED/RESOLVED; onset 2023-09-19 (study day 58); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 79); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-28 (study day 189); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-29 (study day 221); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-08 (study day 229); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 239); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-22 (study day 274); relationship: not assessed

severe serious assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 325); relationship: not assessed; serious criteria: hospitalization

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-06-21 (study day 334); relationship: N

Data queries

No data queries.