A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Xarelto
• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  100000093931

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Venous thrombosis

  Pulmonary embolism

  Atrial fibrillation

  Acute coronary syndrome

Population studied

• Short description of the study population:
  All patients aged 2 years and above who have been registered in the database for at least 1 year before the index date will be included.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  To assess patterns of drug utilization and to quantify outcomes related to safety and effectiveness in new users of rivaroxaban compared with new users of standard of care in routine clinical practice in the Netherlands.
• Outcomes:
  1. Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time 2. Characteristics of rivaroxaban use in comparison with standard of care (NOTE: please refer to https://clinicaltrials.gov/ for description of further primary outcomes), Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care. (NOTE: please refer to https://clinicaltrials.gov/ for description of further secondary outcomes)
• Data analysis plan:
  For descriptive purposes, annualized crude incidence rates of the specified outcome events will be calculated, accompanied by 95% confidence intervals.

Documents

Results tables

EUPAS11141-43170

Study report

16646_Progress Report_v1.0_2019-01-28

EUPAS11141-43221