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 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
NCT ID:
NCT03615105
Group ID:
EG000
Title:
Radiation, Thiotepa & Cyclophosphamide
Description:
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
3
Other Number Affected:
3
Other Number At Risk:
3
Study:
NCT03615105
Results Section:
NCT03615105
Adverse Events Module:
NCT03615105