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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02836457

Enrollment

1134

Registered

2016-07-19

Start date

2016-07-01

Completion date

2018-07-31

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
The incidence of venous thromboembolism (VTE)	52 Weeks

Countries

Japan

Outcome results