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Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02007655
Enrollment
6372
Registered
2013-12-11
Start date
2013-09-01
Completion date
2016-08-31
Last updated
2022-06-07

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

Conditions

NonValvular Atrial Fibrillation

Keywords

Cardiovascular

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

Interventions

Sponsors

Pfizer
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Incidence rate of unexpected adverse eventsDay 1 (At Eliquis initiation)
Bleeding events and risk factors of bleedingDay 1 (At Eliquis initiation)
Ancillary baseline variables that may also be associated with adverse outcomesDay 1 (At Eliquis initiation)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026