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 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:12 PM
NCT ID:
NCT00978432
Group ID:
EG000
Title:
Arm 1a (RAD001 Followed by LBH589)
Description:
Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
10
Other Number Affected:
10
Other Number At Risk:
10
Study:
NCT00978432
Results Section:
NCT00978432
Adverse Events Module:
NCT00978432