A European, non-interventional, multicentre, registry-based post-authorisation safety study to evaluate the long-term safety of Loargys treatment in arginase 1 deficiency patients in standard clinical care

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  European registry and network for intoxication type metabolic diseases
• Data source(s), other:
  Sponsor’s global safety database
• Data sources (types):
  Non-interventional 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