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 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
NCT ID:
NCT01856257
Group ID:
EG001
Title:
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept
Description:
Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
21
Serious Number At Risk:
29
Other Number Affected:
24
Other Number At Risk:
29
Study:
NCT01856257
Results Section:
NCT01856257
Adverse Events Module:
NCT01856257