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 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
NCT ID:
NCT02424851
Group ID:
EG000
Title:
Arm A (BBD)
Description:
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
16
Other Number Affected:
15
Other Number At Risk:
16
Study:
NCT02424851
Results Section:
NCT02424851
Adverse Events Module:
NCT02424851