An observational post-authorization Modified Prescription-Event Monitoring safety study to monitor the safety and utilization of rivaroxaban (XARELTO®) for the prevention of stroke in patients with AF, treatment of DVT and PE, and prevention of recurrent DVT and PE following an acute DVT in the primary care setting in England, extended to include Acute Coronary Syndrome Patients (Rivaroxaban MPEM)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  XARELTO

Population studied

• Short description of the study population:
  Patients prescribed rivaroxaban in the primary care setting in England.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Estimation of the cumulative incident risk (separately) of the following important identified risk for rivaroxaban users which is:• Haemorrhage within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites.
• Outcomes:
  The incidence risk of:(a) all major bleeding specified in primary objective for rivaroxaban (as composite)(b) (separately) haemorrhage within critical organ sites other than specified in primary objective for rivaroxaban(d) all major and clinically relevant non-major bleeds (as a composite outcome)(e) thromboembolic complications (incident and recurrent)
• Data analysis plan:
  PEM methodology provides a numerator (the number of reports of an event) and a denominator (the number of patient-months at risk), both collected within a known time frame. This allows for the calculation of risk (percent of total valid cohort exposed) and incidence densities (ID, person-time incidence rates) for each event. Such analyses will be performed using ‘Higher-level’ event terms from the MedDRA dictionary.