Kesimpta (ofatumumab) pregnancy and infant safety study using real world data

ENCePP Code of conduct

No

Data sources

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

  Danish registries (access/analysis)
• Data source(s), other:
  - Birth Defects Registry, Sweden; - Birth Defect Registry, Denmark; - Healthcore Integrated Research Database, United States
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

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