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The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population with Exposure to ELIQUIS (APIXABAN) |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all treatment-related adverse events ( AE) | 52 Weeks | |
| The incidence of serious adverse events (SAE) | 52 Weeks | |
| The incidence of unexpected treatment-related adverse events | The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events | 52 Weeks |
| The incidence of bleeding | The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of venous thromboembolism (VTE) | 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Shinjuku-ku | Tokyo | 162-0822 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| Investigator Inquiry Form |
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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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