PaTernal exposure to vAlproate, further iNvestiGation on the risk of NeuroDevelopmental Disorders (NDD) and Major Congenital Malformation (MCM) in Offspring: A Non-Interventional Post-Authorization Safety Study (TANGO)

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  German Pharmacoepidemiological Research Database

  Lääketoimitukset (Kanta - Reseptikeskus)

  The Norwegian Prescribed Drug Registry

  Swedish Cause of Death Register

  Sweden National Prescribed Drugs Register / Läkemedelsregistret
• Data source(s), other:
  - DENMARK: Danish Civil Registration System, National Prescription Registry, National Patient Registry, Cause of death register, Medical Birth Registry, The IVF Register, The Danish Psychiatric Central Research Register, Danish National Hospital Medication Register,; - FINLAND: Population register, Care register for Health care, Prescription register, Kanta electronic prescriptions, Special Reimbursement Register, Causes of Death register, medical births register, Register of Medical abortions, Register of Congenital malformations,; - NORWAY: Population Registry, Norwegian Prescribed Drug Registry, Norwegian Patient Registry, Medical Birth Registry of Norway, Cause of Death Registry, National Education Database, ; - SWEDEN : Multigenerational register, Cause of death register, National prescription registry, National patient registry, medical birth registry, Population Register.;
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Birth registry

  Congenital anomaly registry

  Death registry

  Drug prescriptions

  Population registry

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:
  Unknown