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 @ 12:14 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
NCT ID:
NCT02921061
Group ID:
EG000
Title:
Treatment (Decitabine 20 mg/m2 and G-CLAM)
Description:
Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3).
Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM.
Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks).
Deaths Number Affected:
19
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
28
Other Number Affected:
28
Other Number At Risk:
28
Study:
NCT02921061
Results Section:
NCT02921061
Adverse Events Module:
NCT02921061