NCT02345343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 4, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2015

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

January 16, 2015

Last Update Submit

June 27, 2017

Conditions

Deep Vein ThrombosisPulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Drug: 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

Drug: Apixaban

Interventions

ApixabanDRUG
Also known as: Eliquis
Drug: Apixaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sentinel site for the CNFV in Mexico

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Querétaro, 76000, Mexico

Location

Related Links

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 26, 2015

Study Start

May 4, 2015

Primary Completion

October 7, 2015

Study Completion

October 7, 2015

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

ME(1)