A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Danish registries (access/analysis)
• Data source(s), other:
  National Health Data System - SNDS, Rheuma-Kindwunsch und Schwangerschaft - RHEKISS, HealthCore Integrated Research Database - HIRD United States, Finnish Registries, DAPI database
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Pharmacy dispensing records, Hospital medication registries

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