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| ID | Type | Description | Link |
|---|---|---|---|
| XA1402 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban. |
| |
| Standard of care | Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of major bleedings defined as overt bleeding | Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site | Up to 2 years |
| Number of patients with symptomatic recurrent venous thromboembolic events | Up to 2 years | |
| All cause mortality | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse cardiovascular events | Number of cardiovascular events will be used for descriptive statistics to summarize safety variables. | Up to 2 years |
| Number of patients with other symptomatic thromboembolic events |
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Inclusion Criteria:
Exclusion Criteria:
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In- and outpatients in sites participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Algeria | |||||
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| Recommended VTE pharmacological treatments according to international guidelines | Drug | Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine. |
|
| Up to 2 years |
| Treatment satisfaction (patient reported outcomes) | Up to 2 years |
| Multiple Locations |
| Egypt |
| Multiple Locations | Indonesia |
| Multiple Locations | Jordan |
| Multiple Locations | Kazakhstan |
| Multiple Locations | Kenya |
| Multiple Locations | Kuwait |
| Multiple Locations | Lebanon |
| Multiple Locations | Malaysia |
| Multiple Locations | Mexico |
| Multiple Locations | Morocco |
| Multiple Locations | Philippines |
| Multiple Locations | Qatar |
| Multiple Locations | Russia |
| Multiple Locations | Saudi Arabia |
| Multiple Locations | Singapore |
| Multiple Locations | South Korea |
| Multiple Locations | Taiwan |
| Multiple Locations | Turkey (Türkiye) |
| Multiple Locations | Ukraine |
| Multiple Locations | United Arab Emirates |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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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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