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 @ 12:37 PM
Ignite Modification Date:
2025-12-25 @ 12:11 PM
NCT ID:
NCT00452361
Group ID:
EG000
Title:
Sirolimus (SRL)
Description:
SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
21
Other Number Affected:
78
Other Number At Risk:
21
Study:
NCT00452361
Results Section:
NCT00452361
Adverse Events Module:
NCT00452361