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:
EG002
Title:
Intermediate-risk Group (Regimen F)
Description:
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)
Cisplatin: Given IV
Dexrazoxane: Given IV
Doxorubicin Hydrochloride: Given IV
Fluorouracil: Given IV
Laboratory Biomarker Analysis: Correlative studies
Liver Transplantation: Undergo liver transplant
Therapeutic Conventional Surgery: Undergo surgery
Vincristine Sulfate: Given IV
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
102
Other Number Affected:
91
Other Number At Risk:
102
Study:
NCT00980460
Results Section:
NCT00980460
Adverse Events Module:
NCT00980460