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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Querétaro, 76000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Other names: Eliquis

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 26, 2015
Registry last updated: Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed