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 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 1:47 PM
NCT ID:
NCT00068692
Group ID:
EG004
Title:
Group II, Arm I
Description:
Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV
Deaths Number Affected:
11
Deaths Number At Risk:
None
Serious Number Affected:
21
Serious Number At Risk:
31
Other Number Affected:
6
Other Number At Risk:
31
Study:
NCT00068692
Results Section:
NCT00068692
Adverse Events Module:
NCT00068692