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 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
NCT ID:
NCT01253460
Group ID:
EG000
Title:
Cyclophosphamide, Rituximab + Sapacitabine
Description:
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
18
Other Number Affected:
18
Other Number At Risk:
18
Study:
NCT01253460
Results Section:
NCT01253460
Adverse Events Module:
NCT01253460