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| ID | Type | Description | Link |
|---|---|---|---|
| WWE116951 | Other Identifier | GSK | |
| EPI40685 | Other Identifier | GSK |
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The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.
Patients eligible for the study are patient who experienced a TEE during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation.
All information will collected by medical record review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who experienced a thromboembolic event | Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Eltrombopag exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation. | An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review. | The patients will be followed from 5 years from first occurrence of thromboembolic event. |
| New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation. | An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review. | The patients will be followed from 5 years from first occurrence of thromboembolic event. |
| Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation. | An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review. | The patients will be followed from 5 years from first occurrence of thromboembolic event. |
| Evaluation for liver transplant and result of evaluation. | An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients under study are patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| The patients will be followed from 5 years from first occurrence of thromboembolic event. |
| Liver transplantation. Patients who experienced a Liver transplantation during study participation. | An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review. | The patients will be followed from 5 years from first occurrence of thromboembolic event. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |