POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Name of medicine:
  ELIQUIS

Population studied

• Short description of the study population:
  Patients identified in the database who have received an apixaban dispensation during the study period 01 Jan 2012 through 31 Dec 2014.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  17592

Study design details

• Main study objective:
  The overall objective of this study is to describe the utilization patterns of apixaban in Sweden.
• Outcomes:
  Off label use of apixaban.
• Data analysis plan:
  Descriptive analyses of the data will be conducted. The proportionof patients receiving the drug for indications within and outside the approved label in each of the study years will be estimated and any trend over time will be described.