An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among Patients Treated with Tofacitinib for Moderately to Severely Active Rheumatoid Arthritis (RA) within the Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) register. (Safety of tofacitinib in ARTIS)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  Sweden National Cancer Register / Cancerregistret

  Swedish Cause of Death Register
• Data source(s), other:
  Swedish Rheumatology Quality Register (SRQ), Anti-Rheumatic Treatment in Sweden (ARTIS), SRQ/ARTIS linkage, Swedish Patient Register, Contagious Disease Register, Medical Birth Register, Total Population Register
• Data sources (types):
  Disease registry

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

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

Procedures

No information provided.