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:
EG004
Title:
High-risk Group (Regimen H)
Description:
Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT 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 4 courses of VIT 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. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Fluorouracil: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Liver Transplantation: Undergo liver transplant
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo surgery
Vincristine Sulfate: Given IV
Deaths Number Affected:
13
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
36
Other Number Affected:
32
Other Number At Risk:
36
Study:
NCT00980460
Results Section:
NCT00980460
Adverse Events Module:
NCT00980460