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 @ 5:07 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
NCT ID:
NCT00978250
Group ID:
EG000
Title:
5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Description:
FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles
5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Deaths Number Affected:
8
Deaths Number At Risk:
None
Serious Number Affected:
38
Serious Number At Risk:
93
Other Number Affected:
91
Other Number At Risk:
93
Study:
NCT00978250
Results Section:
NCT00978250
Adverse Events Module:
NCT00978250