European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Danish registries (access/analysis)

  Integrated Primary Care Information (IPCI)

  The Information System for Research in Primary Care (SIDIAP)

  German Pharmacoepidemiological Research Database

  Système National des Données de Santé (French national health system main database)
• Data source(s), other:
  Health Search Database (HSD), Italy
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  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