Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02107651

Enrollment

Registered

2014-04-08

Start date

2013-01-31

Completion date

2014-04-30

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding as Complication to Anticoagulation Therapy

Keywords

Bleeding, Anticoagulation

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients admitted for GI bleeding while in treatment with NOAC

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame
Proportion of patients admitted with adverse event reported to authorities	Within one year of admission

Countries

Denmark

Outcome results