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 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 10:19 AM
NCT ID:
NCT01158261
Group ID:
EG000
Title:
EVICEL® Fibrin Sealant (Human)
Description:
An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator's assessment.
In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
22
Serious Number At Risk:
300
Other Number Affected:
23
Other Number At Risk:
300
Study:
NCT01158261
Results Section:
NCT01158261
Adverse Events Module:
NCT01158261