Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Completed

• Conditions: NonValvular Atrial Fibrillation
• Interventions: Drug: Eliquis

• Registration Number: NCT02007655
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary objectives of this study are:

* To estimate the incidence rate of unexpected adverse events

* To characterize the bleeding events and assess risk factors of bleeding

* To identify ancillary baseline variables that may also be associated with adverse outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-11
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6372

Inclusion Criteria

• Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

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Exclusion Criteria

• Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eliquis on Nonvalvular Atrial Fibrilliation patients	Eliquis	Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study

Primary Outcome Measures

Name	Time	Method
Incidence rate of unexpected adverse events	104 week (discontinuation)
Bleeding events and risk factors of bleeding	104 week (discontinuation)
Ancillary baseline variables that may also be associated with adverse outcomes	104 week (discontinuation)

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Toyama-shi, Toyama, Japan