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:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
NCT ID:
NCT01672866
Group ID:
EG003
Title:
Open-Label Phase: SIM 125 mg
Description:
All participants who completed the Blinded Phase through the Week 240 visit, or were ongoing at the time the study stopped, or who had progressed cirrhosis of the liver, were offered the opportunity to receive open-label SIM for up to 240 additional weeks. Additionally, participants who developed confirmed progression to cirrhosis prior to completing the Blinded Phase were eligible to roll over into the open-label phase. Adverse events reported in this group occurred during the Open-Label Phase. All participants received fixed-dose open-label SIM 125 mg via subcutaneous injection every week for up to 240 weeks.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
42
Other Number Affected:
29
Other Number At Risk:
42
Study:
NCT01672866
Results Section:
NCT01672866
Adverse Events Module:
NCT01672866