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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
NCT ID:
NCT00616967
Group ID:
EG000
Title:
Run-in Phase (Arm 0)
Description:
Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).
Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally
Events summarized in this arm are those that met 5% reporting threshold in Arms I and II.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT00616967
Results Section:
NCT00616967
Adverse Events Module:
NCT00616967