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 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
NCT ID:
NCT02004704
Group ID:
EG001
Title:
Olipudase Alfa: Participants From DFI13803 (Pediatrics)
Description:
Participants continued to receive olipudase alfa at the same dose as at the completion of original study-DFI13803 (up to 3.0 mg/kg) via IV infusion every 2 weeks for 9 years, or until olipudase alfa was commercially accessible, whichever came first, unless the participant decided to enter another olipudase alfa clinical trial within the 9-year period prior to when olipudase alfa was commercially accessible. During the study, pediatric participants who reached adult age (18 years old) received the adult infusion volume.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
10
Serious Number At Risk:
20
Other Number Affected:
20
Other Number At Risk:
20
Study:
NCT02004704
Results Section:
NCT02004704
Adverse Events Module:
NCT02004704