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 @ 2:01 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
NCT ID:
NCT00221195
Group ID:
EG001
Title:
Prophylaxis Period
Description:
During the prophylaxis period, AICC was administered at a target dose of 85 U per kilogram (±15%) (range, 72 to 98) on 3 nonconsecutive days weekly. Bleeding episodes during the prophylaxis period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.
There were 3 subjects that never received prophylaxis therapy, therefore 31 subjects were assessed for AEs during this period.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
31
Other Number Affected:
17
Other Number At Risk:
31
Study:
NCT00221195
Results Section:
NCT00221195
Adverse Events Module:
NCT00221195