Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Belatacept + MPA | subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus: 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): 40-60% of the previous dose Day 21 (\~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue MPA: administered according to SOC belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention | 0 | None | 0 | 9 | 6 | 9 | View |
| Belatacept + Low-Dose Tac | 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 | 1 | None | 1 | 8 | 7 | 8 | View |
| Tacrolimus + MPA Standard Treatment Regimen | Standard of Care treatment regimen: Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter. MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper. MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator. 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 MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention | 1 | None | 1 | 10 | 7 | 10 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CMV | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| BK infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperlipidemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |