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 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
NCT ID:
NCT02105766
Group ID:
EG000
Title:
Female Participants With SCD or Beta-thalassemia Receiving Stem Cell Transplant With Male Donor
Description:
Female participants with Sickle Cell Disease (SCD) or Beta-thalassemia receiving stem cell transplant with male donor. Pentostatin given on days -21, -17, -13, -9 and oral cyclophosphamide from days -21 to -8, with the intention to be administered in the outpatient setting. Alemtuzumab on days 7 to 3, and 300 cGy TBI on day 2. Sirolimus started at a loading dose of 5mg PO every 4 hours for three doses on day -1 and adjusted to maintain trough levels between 10-15 ng/mL. The PBSC graft targeted to deliver .10 x 106 CD34+ cells/kg (minimum .5 x 106) and infused on day 0.
Alemtuzumab: Immunosuppressant
Sirolimus: Immunosuppressant
Cyclophosphamide: Immunosuppressant
Pentostatin: Immunosuppressant
Radiotherapy: Immunosuppressant and myelosuppressant
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT02105766
Results Section:
NCT02105766
Adverse Events Module:
NCT02105766