Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
NCT ID:
NCT04311502
Group ID:
EG000
Title:
Arm1
Description:
Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.
Doses (administered orally once daily): rifapentine, 1200mg; isoniazid, 300mg; pyrazinamide, 40 to \<55kg 1000mg, 55to \<71kg 1500mg; ≥71kg 2000mg; ethambutol, 40 to \<55kg 800mg, 55to \<71kg 1200mg; ≥71 kg 1600mg
Rifapentine: 1200 mg once daily
Isoniazid: 300 mg once daily
Pyrazinamide: 1000mg once daily if weight is 40 to \<55kg 1500mg once daily if weight is 55to \<71kg 2000mg once if weight is ≥71kg
Ethambutol: 800 mg once daily if weight is 40 to \<55kg 1200 mg once daily if weight is 55 to \<71kg 1600mg once if weight is ≥71kg
Clofazimine: 300 mg once daily for 2 weeks (loading dose). 100 mg once daily
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
8
Serious Number At Risk:
58
Other Number Affected:
25
Other Number At Risk:
58
Study:
NCT04311502
Results Section:
NCT04311502
Adverse Events Module:
NCT04311502