An active surveillance, post-authorization safety study of serious infection, malignancy, cardiovascular and other safety events of interest among patients treated with tofacitinib for moderately to severely active rheumatoid arthritis within the Spanish registry of adverse events of biological therapies and biosimilars in rheumatoid diseases (BIOBADASER) (Safety of tofacitinib in BIOBADASER)

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  Spanish Registry of Adverse Events of Biological Therapies and Biosimilars in Rheumatoid Diseases (BIOBADASER)
• Data sources (types):
  Disease registry

  Drug dispensing/prescription data

  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