Prospective, multinational, non-interventional post-authorisation study to document the long-term immunogenicity, safety, and efficacy of Human-cl rhFVIII (simoctocog alfa) in patients with haemophilia A treated in routine clinical practice (GENA-99)

24/11/2015
11/10/2021
EU PAS number:
EUPAS7905
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

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