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 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
NCT ID:
NCT03226418
Group ID:
EG000
Title:
Group I
Description:
INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.
INTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.
Cytarabine: Given IV
Idarubicin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
8
Other Number Affected:
7
Other Number At Risk:
8
Study:
NCT03226418
Results Section:
NCT03226418
Adverse Events Module:
NCT03226418