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

Bristol-Myers Squibb100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Deep Vein Thrombosis Pulmonary Embolism

Interventions

ApixabanDRUG

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 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

Locations (1)

Local Institution

Querétaro, Mexico

Outcomes

Primary Outcomes

The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians

Time frame: Up to 24-month study period

Secondary Outcomes

The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE

Time frame: Up to 24-month study period

Data from ClinicalTrials.gov

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