A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS) (GZ402673-OBS13434)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Other
• Data sources (types), other:
  Prospective patient-based data collection, Danish MS registry (DMSR), Belgian MS registry (BELTRIMS), social security databases of Belgium (AIM-IMA), reginal healthcare databases of Lombardy (Italy) (HUCD) are participating to the external comparison cohort study.

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