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 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
NCT ID:
NCT00556933
Description:
None
Frequency Threshold:
5
Time Frame:
Up to two years.
Study:
NCT00556933
Study Brief:
Improved Induction and Maintenance Immunosuppression in Kidney Transplantation
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 1 | Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression. rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection. | None | None | 9 | 44 | 12 | 44 | View |
| Group 2 | Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression. rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection. | None | None | 15 | 44 | 12 | 44 | View |
| Group 3 | Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months. rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i | None | None | 18 | 45 | 11 | 45 | View |
| Group 4 | Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months. mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney. rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve | None | None | 21 | 45 | 8 | 45 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Wound Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Acute Tubular Necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Rabbit Anti-Thymocyte Globulin (rATG) Reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Renal Allograft Primary Non-function | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal Allograft Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Ureteral Stricture | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Lymphocele Requiring Drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Repair of Wound Hernia at Transplantation Incision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Serum Sickness | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):