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 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
NCT ID:
NCT00466960
Group ID:
EG000
Title:
Treatment (Colony Stimulating Factor and Chemotherapy)
Description:
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
21
Other Number Affected:
20
Other Number At Risk:
21
Study:
NCT00466960
Results Section:
NCT00466960
Adverse Events Module:
NCT00466960