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 @ 5:26 PM
Ignite Modification Date:
2025-12-25 @ 3:00 PM
NCT ID:
NCT02213068
Group ID:
EG001
Title:
Belatacept + Low-Dose Tac
Description:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (\~ 2 weeks into study): 10% of the previous dose Day 21 (\~ 3 weeks into study): 20% of the previous dose Day 30 (\~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.
belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
8
Other Number Affected:
7
Other Number At Risk:
8
Study:
NCT02213068
Results Section:
NCT02213068
Adverse Events Module:
NCT02213068