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 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
NCT ID:
NCT01085435
Group ID:
EG000
Title:
EFFORTLESS Main Study
Description:
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
Deaths Number Affected:
91
Deaths Number At Risk:
None
Serious Number Affected:
199
Serious Number At Risk:
984
Other Number Affected:
531
Other Number At Risk:
984
Study:
NCT01085435
Results Section:
NCT01085435
Adverse Events Module:
NCT01085435