Post-Marketing Surveillance on the Use of Prazaxa® (Japanese Prazaxa PMS, second)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective, observational, single arm

Study drug and medical condition

• Name of medicine, other:
  Prazaxa Capsules 75 mg 110 mg
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Adolescents and adults using Prazaxa® Capsules in real-world setting after the availability of idarucizumab.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab.
• Outcomes:
  Incidences of adverse drug reactions
• Data analysis plan:
  Analyses are descriptive in nature, including confidence intervals. Due to the nature of the observational study, no confirmatory statistical testing is foreseen in this study. Subgroup analyses are also performed if sample size allows.