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 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
NCT ID:
NCT00354835
Group ID:
EG001
Title:
VAC Alternating With VI
Description:
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Irinotecan Hydrochloride: Given IV
Dactinomycin: Given IV
Cyclophosphamide: Given IV
Vincristine Sulfate: Given IV
Radiation Therapy: Undergo radiotherapy
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
226
Other Number Affected:
213
Other Number At Risk:
226
Study:
NCT00354835
Results Section:
NCT00354835
Adverse Events Module:
NCT00354835