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| ID | Type | Description | Link |
|---|---|---|---|
| XA1313BE | 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 non-valvular AF 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 | 15 mg OD or 20 mg OD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major bleedings | 1 year or 30 days after end of rivaroxaban | |
| Number of patients with symptomatic thromboembolic events | 1 year or 30 days after end of rivaroxaban | |
| All-cause mortality | 1 year or 30 days after end of rivaroxaban | |
| Adverse events | 1 year or 30 days after end of rivaroxaban | |
| Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) | 1 year or 30 days after end of rivaroxaban | |
| Quantities of resource use consumption | 1 year or 30 days after end of rivaroxaban |
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Inclusion Criteria:
Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation
Patients must in addition present with at least one of following risk factors:
Exclusion Criteria:
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Ambulatory or hospitalized patients coming from the cardiology 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 |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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