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 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
NCT ID:
NCT04672460
Group ID:
EG003
Title:
Maintenance
Description:
Participants who had repeated a period 2 times but still could not meet PK evaluable criteria, needed a dose reduction, had unstable renal function, had experienced renal function worsening to moderate/severe renal impairment during the study, or had completed the food effect assessment, was rolled over to the maintenance phase which consisted of repeating 28 day cycles of treatment with the current commercial formulation.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
41
Other Number Affected:
20
Other Number At Risk:
41
Study:
NCT04672460
Results Section:
NCT04672460
Adverse Events Module:
NCT04672460