Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico
- Registration Number
- NCT02345343
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Drug: Apixaban Apixaban Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site
- Primary Outcome Measures
Name Time Method The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians Up to 24-month study period
- Secondary Outcome Measures
Name Time Method The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE Up to 24-month study period
Trial Locations
- Locations (1)
Local Institution
🇲🇽Queretaro, Mexico