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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
NCT ID:
NCT00085293
Group ID:
EG000
Title:
Treatment
Description:
Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m\^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
12
Other Number Affected:
11
Other Number At Risk:
12
Study:
NCT00085293
Results Section:
NCT00085293
Adverse Events Module:
NCT00085293