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.
Study Type
OBSERVATIONAL
Enrollment
22
Eltrombopag exposure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
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