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 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
NCT ID:
NCT02057718
Group ID:
EG000
Title:
Safety Population
Description:
The safety population is defined as all subjects who were assigned and received at least one dose of the study drug. Safety analysis consists of the MITT population (Modified Intent-to-Treat \[MITT\]). The arms have been combined to have one larger analysis population, thus allowing for a more robust understanding of the incidence rates of AEs for patients with PFIC treated with Maralixibat.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
33
Other Number Affected:
33
Other Number At Risk:
33
Study:
NCT02057718
Results Section:
NCT02057718
Adverse Events Module:
NCT02057718