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 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
NCT ID:
NCT01901432
Group ID:
EG002
Title:
Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)
Description:
Following initial assignment of 3 patients to DL1 in Part A, a further 3 patients were assigned to DL1 so this treatment group is referred to as "DL1 expanded" (patients received givinostat by oral administration at 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).
There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
3
Other Number Affected:
3
Other Number At Risk:
3
Study:
NCT01901432
Results Section:
NCT01901432
Adverse Events Module:
NCT01901432