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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
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The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.
Time Perspective: Prospective design, Retrospective data collection and analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated with Belatacept at the time of transplantation | Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept at the time of transplantation | ||
| Patient treated with CNI at the time of transplantation | Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with a Calcineurin inhibitor (CNI) based regimen at the time of transplantation |
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| Measure | Description | Time Frame |
|---|---|---|
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus | At the time of transplantation | |
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus | 1 year post transplantation | |
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus | 2 year post transplantation | |
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus | 3 year post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept | At transplantation, 12 month, 24 month and 36 month post transplantation | |
| Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation |
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Inclusion Criteria:
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Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| FDA Safety Alerts and Recalls | View source |
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| At the time of transplantation |
| Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant | At transplantation and 12 month post transplantation |