ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE
Completed
- Conditions
- Venous Thromboembolism
- Registration Number
- NCT02836457
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1134
Inclusion Criteria
- Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time
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Exclusion Criteria
- Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
- Patients initiating Eliquis for the treatment of atrial fibrillation
- Off-label use of Eliquis
Other protocol defined inclusion/exclusion criteria could apply
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of all treatment-related adverse events ( AE) 52 Weeks The incidence of serious adverse events (SAE) 52 Weeks The incidence of unexpected treatment-related adverse events 52 Weeks The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events
The incidence of bleeding 52 Weeks The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events
- Secondary Outcome Measures
Name Time Method The incidence of venous thromboembolism (VTE) 52 Weeks
Trial Locations
- Locations (1)
Local Institution
🇯🇵Shinjuku-ku, Tokyo, Japan