A Drug Utilization Study to Evaluate the Effectiveness of Risk Minimization Measures (RMMs) for Abrocitinib in the EU Using Electronic Healthcare Data (B7451085)

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  Système National des Données de Santé (French national health system main database)

  The Information System for Research in Primary Care (SIDIAP)

  Danish registries (access/analysis)

  Swedish Cause of Death Register
• Data source(s), other:
  Denmark: Danish National Patient Register, Danish Hospital Medicines Register, Danish Cancer Registry, Danish Register of Laboratory Results, Danish Medical Birth Registry; ; France: the French nationwide administrative database (Système National des Données de Santé (SNDS); Sweden: Swedish National Health Registers (including the National Patient Register, Prescribed Drug Register, Total Population Register, Swedish Cause of Death Register, and Swedish Medical Birth Register); ; Spain: the Information System for Research in Primary Care (SIDIAP); and ; Hungary: the National Insurance Fund Administration (NHIFA) database (including the following NHIFA registers: Demography, Drugs, Inpatient, and Outpatient).
• Data sources (types):
  Non-interventional study

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:
  Not applicable