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 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT03343704
Group ID:
EG001
Title:
Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure
Description:
Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.
Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT03343704
Results Section:
NCT03343704
Adverse Events Module:
NCT03343704