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
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

APIXABAN
Population studied

Short description of the study population

Any patient receiving apixaban in Denmark recorded in routine outpatient dispensation records.

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)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

8000
Study design details

Main study objective

The objective of this study is to describe the utilisation pattern of apixaban in Denmark with regard to on-label and off-label use.

Data analysis plan

Data will be collected on apixaban dispensations, prescriber specialty, and patient characteristics such as age, gender, morbidities, concomitant medications, and hospital-based diagnoses and procedures. Patients will be classified as on-label or off-label users if their initial indication has been recorded or can be inferred from the registry data. If an apixaban indication is not present or cannot be inferred from the registries, the patients’ indications will be considered unknown. Information will be drawn from the Danish Civil Registration System (DCRS), Danish National Patient Register (DNPR), and the National Health Service Prescription Database (NHSPD).
Documents
Study report

B0661073 Apixaban DUS FINAL REPORT

English (1.39 MB - PDF)View document
Study publications
Vinter N, Linder M, Andersen M, Pedersen AB, Madsen M, Schachterle SE, Ataher Q…