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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• 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

• Medicinal product name:
  PRADAXA
• Medicinal product name, other:
  Prazaxa Capsules 75 mg 110 mg
• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• 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:
  • Adults (46 to < 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:
  Primary outcome:; Absolute and relative (%) frequency of patients with suspected adverse ; drug reactions (ADRs).; Secondary outcome; None; Further outcomes:; Incidence of stroke/SEE; Incidence of bleeding; Incidence of myocardial infarction (MI); Incidence of gastrointestinal (GI) disorder
• 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.