A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab (SIMA PASS)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Danish registries (access/analysis)

  The Information System for Research in Primary Care (SIDIAP)
• Data source(s), other:
  SNDS France, SHI Germany
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Drug dispensing/prescription data

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  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