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

29/11/2024
07/01/2025
EU PAS number:
EUPAS1000000345
Study
Ongoing

ENCePP Code of conduct

Yes
Data sources

Data source(s)

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
Procedures
No information provided.