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| ID | Type | Description | Link |
|---|---|---|---|
| ELICUIS FV MEXICO | Other Identifier | Alias Study Number |
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Company decision to not conduct the study and was cancelled prior to any enrollment.
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To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
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| Measure | Description | Time Frame |
|---|---|---|
| the number and type of suspected adverse drug reactions, including serious and non-serious cases | To characterize and to analyze the number, type and incidence of suspected adverse drug reaction (SADRs) in patients receiving apixaban according to the therapeutic indications approved in Mexico: A. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors as prior stoke or transient ischaemic attack; age >75; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class >II) B. and in prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery | 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who have received at least one dose of apixaban for prevention stroke and systemic embolism with non-valvular atrial fibrillation or for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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