ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE

Bristol-Myers Squibb1,134 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,134

Conditions

Venous Thromboembolism

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time 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

Locations (1)

Local Institution

Shinjuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

The incidence of all treatment-related adverse events ( AE)

Time frame: 52 Weeks

The incidence of serious adverse events (SAE)

Time frame: 52 Weeks

The incidence of unexpected treatment-related adverse events

The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events

Time frame: 52 Weeks

The incidence of bleeding

The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events

Time frame: 52 Weeks

Secondary Outcomes

The incidence of venous thromboembolism (VTE)

Time frame: 52 Weeks

Data from ClinicalTrials.gov

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