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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
NCT ID:
NCT01824693
Group ID:
EG000
Title:
Arm I (Busulfan, Cyclophosphamide, Melphalan)
Description:
CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.
TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.
Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT
Busulfan: Given IV
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given IV or PO
Pharmacological Study: Correlative studies
Tacrolimus: Given IV or PO
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
6
Other Number Affected:
5
Other Number At Risk:
6
Study:
NCT01824693
Results Section:
NCT01824693
Adverse Events Module:
NCT01824693