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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
NCT ID:
NCT00509093
Group ID:
EG000
Title:
Imatinib Mesylate
Description:
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
Deaths Number Affected:
20
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
32
Other Number Affected:
30
Other Number At Risk:
32
Study:
NCT00509093
Results Section:
NCT00509093
Adverse Events Module:
NCT00509093