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:
EG007
Title:
DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
Description:
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received macitentan 10 mg along with tadalafil 20 mg and placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
Deaths Number Affected:
9
Deaths Number At Risk:
None
Serious Number Affected:
39
Serious Number At Risk:
107
Other Number Affected:
89
Other Number At Risk:
107
Study:
NCT03904693
Results Section:
NCT03904693
Adverse Events Module:
NCT03904693