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Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02345343
Enrollment
100
Registered
2015-01-26
Start date
2015-05-04
Completion date
2015-10-07
Last updated
2017-06-28

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

Conditions

Deep Vein Thrombosis, Pulmonary Embolism

Brief summary

The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.

Interventions

DRUGApixaban

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
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 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period

Exclusion criteria

* Subjects who received apixaban as part of a clinical trial * Subjects who received apixaban for any indication other than local approved * Contraindications included in the approved Mexican prescribing information

Design outcomes

Primary

MeasureTime frame
The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physiciansUp to 24-month study period

Secondary

MeasureTime frame
The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AEUp to 24-month study period

Countries

Mexico

Outcome results

None listed

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