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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer-associated thrombosis | Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 15/20 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Venous thromboembolism | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 |
| Bleeding (based on the Cunningham algorithm) | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 |
| Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims) | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 |
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Inclusion Criteria:
Exclusion Criteria:
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Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases is used. The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage. The data come from a selection of large employers, health plans, and government and public organizations and contain claims from approximately 100 employers, health plans, and government and public organizations representing about 50 million covered lives across all age groups. The data elements to be used in the proposed study will include health plan enrollment records, participant demographics, inpatient and outpatient medical claims and outpatient prescription drug dispensing records.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US database | New York | New York | 10001 | United States |
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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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| 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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