Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Longitudinal Data Collection from Patients with Spinal Muscular Atrophy (SMArtCARE)
• Data source(s), other:
  ISMAR, United Kingdom-Adult SMA REACH
• Data sources (types):
  Other
• Data sources (types), other:
  The study will be utilizing data within existing SMA (ISMAR-US, SMArtCARE and UK-Adult SMA REACH) registries designed to evaluate pregnancy and birth outcomes in women with SMA who were exposed to nusinersen.

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