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
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
NCT ID:
NCT01729494
Description:
The definition used for serious adverse events were the same as the standard definition. The definition for adverse events differed only in that the adverse events that were related to immunosuppression were captured and any adverse events of special interest in the study.
Frequency Threshold:
0
Time Frame:
Adverse event data was collected in every patient over a 2 year time period.
Study:
NCT01729494
Study Brief:
Belatacept Early Steroid Withdrawal Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group A | Alemtuzumab + belatacept + mycophenolate mofetil /Enteric coated mycophenolate sodium + early cessation of steroids Alemtuzumab: Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab. Belatacept: Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is the day of transplant. | 2 | None | 58 | 107 | 91 | 107 | View |
| Group B | Rabbit antithymocyte globulin + belatacept + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions. Belatacept: Belatacept is administered via intravenous (IV) infusion according to the FDA label | 4 | None | 66 | 104 | 90 | 104 | View |
| Group C | Rabbit antithymocyte globulin + tacrolimus + mycophenolate mofetil /Enteric coated (EC) mycophenolate sodium + early cessation of steroids rabbit antithymocyte globulin: Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions. Tacrolimus: Tacrolimus will be administered orally twice daily (BID). | 1 | None | 62 | 105 | 92 | 105 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal dysfunction resulting in hospitalization | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Nausea/vomiting or GI requiring hospitalization | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cardiovascular event | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Infection Requiring Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Malignancy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| PTLD | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Mental status changes or neurological AE's | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematologic events | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia WBC < 2000/mm3 | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anemia (Hg < 7gm/dL) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia (PLT < 50,000/mm3) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Gastrointestinal events | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nephrotoxicity events | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Neurologic events | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Electrolyte/metabolic events | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Wound healing | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Musculoskeletal/Bone events | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |