Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors (PASS renal, liver injury, infection, ketoacidosis)

ENCePP Code of conduct

No

Data sources

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

  Clinical Practice Research Datalink
• Data source(s), other:
  HealthCore Integrated Research Database (HIRD)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Drug dispensing/prescription data

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  CPRD linked data sources including: hospital episode statistics inpatient data, Office of National Statistics mortality data, multiple deprivation index data, and Townsend score data. HIRD: Commercially insured population database; Danish Population registries: nationwide hospital 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