Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Study drug and medical condition

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

EDOXABAN TOSYLATE MONOHYDRATE

Medical condition to be studied

Atrial fibrillation
Embolism venous
Population studied

Age groups

  • 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)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women

Estimated number of subjects

1200
Study design details

Main study objective

The aim of this Drug Utilisation Study (DUS) is to provide real-world data related to the current prescription patterns of edoxaban. Study objectives are as follows:• To characterize users of edoxaban,• To evaluate the pattern of use of edoxaban,• To evaluate the effectiveness of the edoxaban Educational Material as a tool for risk minimization.

Data analysis plan

Details of the data analysis strategy will be fully described in a Statistical Analysis Plan (SAP). Briefly, descriptive statistics will be used to characterize prescriber and patient information. Summary statistics for continuous variables will include the number of observations, along with measures of location (means, medians) and variation (e.g. standard deviation, range). Categorical data will include counts and percentages. The 95% CIs will be reported where appropriate. Per country analyses will be performed where reasonable, as some subgroups might be too small to be looked at per country. The data may also be evaluated and presented for other meaningful subgroups of patients (e.g. by patients for which there is missing information).