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:
EG001
Title:
Sirolimus-Free Regimen
Description:
There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
73
Other Number Affected:
54
Other Number At Risk:
73
Study:
NCT00928018
Results Section:
NCT00928018
Adverse Events Module:
NCT00928018