Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration among patients treated with EMPAGLIFLOZIN or DPP-4 inhibitors in Saudi Arabia (Post-authorization safety study in type 2 diabetic)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Drug dispensing/prescription data

  Spontaneous reports of suspected adverse drug reactions

  Other
• Data sources (types), other:
  Prospective patient-based data collection

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