Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry (Kesimpta Pregnancy Registry)

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  - Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW), Germany.; - Organization of Teratology Information Specialists (OTIS), Canada.; - Organization of Teratology Information Specialists (OTIS), United States.
• Data sources (types):
  Disease registry

  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