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 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
NCT ID:
NCT00928018
Group ID:
EG000
Title:
Sirolimus-Containing Regimen
Description:
The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
66
Other Number Affected:
41
Other Number At Risk:
66
Study:
NCT00928018
Results Section:
NCT00928018
Adverse Events Module:
NCT00928018