Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan (Entresto®)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Danish registries (access/analysis)

  Health Search/IQVIA Health Longitudinal Patient Database

  The Information System for Research in Primary Care (SIDIAP)

  PHARMO Data Network

  German Pharmacoepidemiological Research Database

  ARS Toscana
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Drug prescriptions

  Electronic healthcare records (EHR)

  Pharmacy dispensing records

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name (other):
  Study specific CDM

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Unknown