Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

ENCePP Code of conduct

Yes

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

180611_DOI_all

DOI_all

Composition of steering group and observers

20161123_Composition

NoSteeringGroup

Signed code of conduct

empty_file.pdf

Signed code of conduct checklist

empty_file.pdf

Signed checklist for study protocols

empty_file.pdf

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Danish registries (access/analysis)

  The Information System for Research in Primary Care (SIDIAP)

  Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems)
• Data sources (types):
  Administrative data (e.g. claims)

  Disease registry

  Drug dispensing/prescription data

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No