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 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
NCT ID:
NCT01726257
Group ID:
EG002
Title:
Continued Access Cohort
Description:
Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
37
Serious Number At Risk:
154
Other Number Affected:
40
Other Number At Risk:
154
Study:
NCT01726257
Results Section:
NCT01726257
Adverse Events Module:
NCT01726257