Open-label, longitudinal, post-authorisation safety study to assess the safety of Cystadrops in pediatric and adult cystinosis patients in long term use (CYT-DS-001)

14/12/2018
08/04/2019
EU PAS number:
EUPAS25688
Study
Planned

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

Spontaneous reporting system, 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
Procedures
No information provided.