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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT00882206
Group ID:
EG000
Title:
Decitabine / Vorinostat
Description:
This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
\*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m\^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m\^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age \<18 years and 400 mg orally every day for \>18 years on Days 5-33.
methotrexate: \*\*Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 - 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
8
Serious Number At Risk:
13
Other Number Affected:
13
Other Number At Risk:
13
Study:
NCT00882206
Results Section:
NCT00882206
Adverse Events Module:
NCT00882206