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 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
NCT ID:
NCT00238433
Group ID:
EG000
Title:
BuMelTT
Description:
\*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
TREATMENT PLAN:
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
36
Serious Number At Risk:
36
Other Number Affected:
36
Other Number At Risk:
36
Study:
NCT00238433
Results Section:
NCT00238433
Adverse Events Module:
NCT00238433