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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | NVAF patients who were newly initiated on Rivaroxaban for stroke prevention |
| |
| Phenprocoumon | NVAF patients who were newly initiated on Phenprocoumon for stroke prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY597939) | Drug | 15mg, 20mg |
| |
| Phenprocoumon (branded and generics) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis | Within time of drug exposure (Retrospective period of 5 years and 3 months) | |
| Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis | Within time of drug exposure (Retrospective period of 5 years and 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis | Within time of drug exposure (Retrospective period of 5 years and 3 months) | |
| Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients newly initiated with Rivaroxaban or Phenprocoumon with an NVAF diagnosis from January 1, 2012 through December 31, 2015. Patients will be identified from the HRI research database, a complete longitudinal dataset of patients under statutory health insurance in Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
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| Drug |
Individually adjusted dose |
|
| Within time of drug exposure (Retrospective period of 5 years and 3 months) |
| Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis | Within time of drug exposure (Retrospective period of 5 years and 3 months) |
| Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis | Within time of drug exposure (Retrospective period of 5 years and 3 months) |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D010644 | Phenprocoumon |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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