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

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 EHR database who have received an apixaban dispensation during the study period 01 Dec 2011 through 31 Dec 2014.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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)
• Estimated number of subjects:
  896

Study design details

• Main study objective:
  The objective of this study is to describe the utilization patterns of apixaban in the Netherlands.
• 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.

Documents

Study results

study-cv185102st-csr-final-red