Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

N/ACompletedNCT02007655

Bristol-Myers Squibb6,372 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

6,372

Conditions

NonValvular Atrial Fibrillation

Interventions

EliquisDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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 Exclusion Criteria: * Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

Locations (1)

Local Institution

Toyama, Toyama, Japan

Outcomes

Primary Outcomes

Incidence rate of unexpected adverse events

Time frame: Day 1 (At Eliquis initiation)

Incidence rate of unexpected adverse events

Time frame: 12 weeks after initiation

Incidence rate of unexpected adverse events

Time frame: 52 weeks after initiation

Incidence rate of unexpected adverse events

Time frame: 104 week (discontinuation)

Bleeding events and risk factors of bleeding

Time frame: Day 1 (At Eliquis initiation)

Bleeding events and risk factors of bleeding

Time frame: 12 weeks after initiation

Bleeding events and risk factors of bleeding

Time frame: 52 weeks after initiation

Bleeding events and risk factors of bleeding

Time frame: 104 week (discontinuation)

Ancillary baseline variables that may also be associated with adverse outcomes

Time frame: Day 1 (At Eliquis initiation)

Ancillary baseline variables that may also be associated with adverse outcomes

Time frame: 12 weeks after initiation

Ancillary baseline variables that may also be associated with adverse outcomes

Time frame: 52 weeks after initiation

Ancillary baseline variables that may also be associated with adverse outcomes

Data from ClinicalTrials.gov

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