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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
NCT ID:
NCT03904693
Group ID:
EG002
Title:
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
Description:
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
44
Other Number Affected:
31
Other Number At Risk:
44
Study:
NCT03904693
Results Section:
NCT03904693
Adverse Events Module:
NCT03904693