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 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
NCT ID:
NCT02920892
Group ID:
EG003
Title:
Open-Label Period: AFQ056 With Language Intervention
Description:
After 8 months of treatment in the placebo-controlled phase, all subjects had assessments completed and were given the opportunity to enter the open-label extension (OLE) in which all subjects received AFQ056. The OLE began with 2 months of flexible dose titration to each subject's maximum tolerated dose followed by a period of stable treatment. Subjects also continued the language intervention through the extension phase.
The total duration of the OLE depended on when the subject was enrolled into the study and ranged from no open label to 8 months.
The OLE included 46 patients who were previously assigned to placebo and 43 patients who were previously assigned to AFQ056.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
89
Other Number Affected:
76
Other Number At Risk:
89
Study:
NCT02920892
Results Section:
NCT02920892
Adverse Events Module:
NCT02920892