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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Drug: Apixaban

Study type: Observational

Funder types: Industry

Identifiers

NCT02345343

CV185-399

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 1 patient group

Drug: Apixaban

Description:

Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site

Treatment:

Drug: Apixaban