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 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
NCT ID:
NCT02498769
Group ID:
EG000
Title:
Epicardial Botulinum
Description:
After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.
Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
27
Serious Number At Risk:
63
Other Number Affected:
10
Other Number At Risk:
63
Study:
NCT02498769
Results Section:
NCT02498769
Adverse Events Module:
NCT02498769