Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
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.