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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eliquis on Nonvalvular Atrial Fibrilliation patients | Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eliquis | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of unexpected adverse events | Day 1 (At Eliquis initiation) | |
| Incidence rate of unexpected adverse events | 12 weeks after initiation | |
| Incidence rate of unexpected adverse events | 52 weeks after initiation | |
| Incidence rate of unexpected adverse events | 104 week (discontinuation) | |
| Bleeding events and risk factors of bleeding | Day 1 (At Eliquis initiation) | |
| Bleeding events and risk factors of bleeding | 12 weeks after initiation | |
| Bleeding events and risk factors of bleeding | 52 weeks after initiation | |
| Bleeding events and risk factors of bleeding | 104 week (discontinuation) | |
| Ancillary baseline variables that may also be associated with adverse outcomes | Day 1 (At Eliquis initiation) | |
| Ancillary baseline variables that may also be associated with adverse outcomes | 12 weeks after initiation | |
| Ancillary baseline variables that may also be associated with adverse outcomes |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Toyama | Toyama | 930-0194 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31421933 | Derived | Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M. Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study. J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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| 52 weeks after initiation |
| Ancillary baseline variables that may also be associated with adverse outcomes | 104 week (discontinuation) |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |