Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

Completed

• Conditions: Bleeding as Complication to Anticoagulation Therapy

• Registration Number: NCT02107651
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Serious adverse events in patients treated with new oral anticoagulants are underreported.

Detailed Description

The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients admitted with adverse event reported to authorities	Within one year of admission

Trial Locations

Locations (1)

Hvidovre Hospital University of Copenhagen; 🇩🇰 Hvidovre, Denmark