Post-authorisation safety study to assess the risk of urinary tract malignancies in relation to empagliflozin exposure in patients with type 2 diabetes: a multi-database European study (PASS DiabCancer)

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Sweden National Prescribed Drugs Register / Läkemedelsregistret
• Data source(s), other:
  Hospital Episode Statistics, Cancer Registry, ONS mortality statistics United Kingdom, National Patient Register, Swedish Cancer Registry, Cause of Death Register, National Diabetes Register Sweden, Finnish prescription register, Care register for health care (HILMO), Register of primary health care visits (AvoHILMO), Finnish cancer register, Regional EMR records Finland
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Drug prescriptions

  Electronic healthcare records (EHR)

  Other

  Pharmacy dispensing records
• Data sources (types), other:
  Population-wide registers in Sweden and Finland contain information e.g. on medication purchases, hospitalisations, cancers and deaths. UK CPRD contains the anonymised longitudinal medical records managed by GPs working the NHS primary care setting.

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes