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:
2025-12-26 @ 10:35 AM
Ignite Modification Date:
2025-12-26 @ 10:35 AM
NCT ID:
NCT01461928
Group ID:
EG002
Title:
All Participants
Description:
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Deaths Number Affected:
161
Deaths Number At Risk:
None
Serious Number Affected:
339
Serious Number At Risk:
692
Other Number Affected:
643
Other Number At Risk:
692
Study:
NCT01461928
Results Section:
NCT01461928
Adverse Events Module:
NCT01461928