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 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
NCT ID:
NCT00513695
Group ID:
EG000
Title:
Treatment (Neoadjuvant Chemotherapy Before Surgery)
Description:
Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
47
Serious Number At Risk:
68
Other Number Affected:
67
Other Number At Risk:
68
Study:
NCT00513695
Results Section:
NCT00513695
Adverse Events Module:
NCT00513695