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| ID | Type | Description | Link |
|---|---|---|---|
| XA1314BE | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major bleedings | up to 1 year or 30 days after end of rivaroxaban | |
| Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) | up to 1 year or 30 days after end of rivaroxaban | |
| All-cause mortality | up to 1 year or 30 days after end of rivaroxaban | |
| Adverse events | up to 1 year or 30 days after end of rivaroxaban | |
| Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) | up to 1 year or 30 days after end of rivaroxaban | |
| Quantities of resource use consumption | up to 1 year or 30 days after end of rivaroxaban |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Belgium |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |