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To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs) | Approximately 2 years | |
| Patient characteristics that are associated with bleeding among patients taking Eliquis | Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE | For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The incidence proportion will be estimated For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The incidence proportion will be estimated |
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Inclusion Criteria:
Exclusion Criteria:
Patients with prior treatment with Eliquis before enrollment in this study
Patients receiving Eliquis treatment for an indication not approved indication in Korea
Patients meeting any of the following criteria will not be included in the study:
i) Hypersensitivity to the active substance or to any of the excipients
ii) Clinically significant active bleeding
iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
iv) Patients with increased bleeding risk due to such as following diseases:
Recent gastrointestinal ulceration history
Recent intracranial or intracerebral haemorrhage history
Intraspinal or intracerebral vascular abnormalities
Recent brain, spinal or ophthalmic surgery history
Recent brain or spinal injury
Known or suspected oesophageal varices
Arteriovenous malformations
Vascular aneurysms
Patients with malignant neoplasms at high risk of bleeding
i) Unfractionated heparin (UFH)
ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)
iii) Heparin derivatives (fondaparinux, etc)
iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter
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Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Seoul | South Korea |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Approximately 2 years |
| Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE | For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The 95% confidence intervals will be estimated For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The 95% confidence intervals will be estimated | Approximately 2 years |