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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
NCT ID:
NCT01945593
Group ID:
EG001
Title:
BAX 855: Age >= 2 to <12 Years
Description:
Participants of age \>= 2 to \<12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of \>= 3% until at least 100 EDs were reached.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
62
Other Number Affected:
40
Other Number At Risk:
62
Study:
NCT01945593
Results Section:
NCT01945593
Adverse Events Module:
NCT01945593