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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT02031302
Group ID:
EG000
Title:
Lotus Valve (30 Day Follow Up)
Description:
All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.
Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Deaths Number Affected:
22
Deaths Number At Risk:
None
Serious Number Affected:
426
Serious Number At Risk:
1014
Other Number Affected:
96
Other Number At Risk:
1014
Study:
NCT02031302
Results Section:
NCT02031302
Adverse Events Module:
NCT02031302