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 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
NCT ID:
NCT03713320
Group ID:
EG001
Title:
Vorinostat (Randomized)
Description:
Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.
Vorinostat: 100 mg capsules
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
18
Other Number Affected:
18
Other Number At Risk:
18
Study:
NCT03713320
Results Section:
NCT03713320
Adverse Events Module:
NCT03713320