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 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
NCT ID:
NCT01465334
Group ID:
EG000
Title:
Treatment Naive
Description:
Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.
(cycle duration=28 days)
Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3
Participants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B.
Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26
Participants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B.
Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
15
Other Number Affected:
15
Other Number At Risk:
15
Study:
NCT01465334
Results Section:
NCT01465334
Adverse Events Module:
NCT01465334