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 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
NCT ID:
NCT00980460
Group ID:
EG003
Title:
High-risk Group (Regimen W)
Description:
(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Fluorouracil: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
Vincristine Sulfate: Given IV
Deaths Number Affected:
11
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
31
Other Number Affected:
27
Other Number At Risk:
31
Study:
NCT00980460
Results Section:
NCT00980460
Adverse Events Module:
NCT00980460