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| ID | Type | Description | Link |
|---|---|---|---|
| XA0801 | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The main goal is to provide additional information to the risk-benefit assessment of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made |
| Measure | Description | Time Frame |
|---|---|---|
| Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality | During observation period of three months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment has been made
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24154549 | Background | Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24. | |
| 22701330 |
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| Standard care treatment for VTE prophylaxis | Drug | Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made |
|
| Many Locations |
| Austria |
| Many Locations | Belgium |
| Many Locations | Bosnia and Herzegovina |
| Many Locations | Brazil |
| Many Locations | Canada |
| Many Locations | Chile |
| Many Locations | China |
| Many Locations | Colombia |
| Many Locations | Cyprus |
| Many Locations | Czechia |
| Many Locations | Denmark |
| Many Locations | Estonia |
| Many Locations | Finland |
| Many Locations | France |
| Many Locations | Germany |
| Many Locations | Greece |
| Many Locations | Hong Kong |
| Many Locations | Hungary |
| Many Locations | India |
| Many Locations | Italy |
| Many Locations | Latvia |
| Many Locations | Lebanon |
| Many Locations | Lithuania |
| Many Locations | Mexico |
| Many Locations | Netherlands |
| Many Locations | North Macedonia |
| Many Locations | Norway |
| Many Locations | Philippines |
| Many Locations | Portugal |
| Many Locations | Serbia |
| Many Locations | Singapore |
| Many Locations | Slovakia |
| Many Locations | South Africa |
| Many Locations | South Korea |
| Many Locations | Spain |
| Many Locations | Sweden |
| Many Locations | Switzerland |
| Many Locations | United Arab Emirates |
| Many Locations | United Kingdom |
| Many Locations | Venezuela |
| Many Locations | Vietnam |
| Derived |
| Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1. |
| 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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