A post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States (220149)

Data sources

• Data source(s), other:
  US FDA Sentinel System (CVS Health, Carelon Research, HealthPartners, Humana, Point32Health)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  Sentinel
• CDM website:
  https://www.sentinelinitiative.org/methods-Data-tools/sentinel-common-Data-model

• CDM version:
  8.2.0

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes