Eliquis Regulatory Post Marketing Surveillance (rPMS)

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Apixaban

• Registration Number: NCT01885585
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Study Start: 2014-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Signed data release
• Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion Criteria

• Being treated for an indication not approved for the use of Eliquis® in Korea
• Is contraindicated for the use of Eliquis® as described in the Korean label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with risk of VTE	Apixaban	Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs) and serious AEs	Up to 30 days after last study drug dose

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of