Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

This is a retrospective, observational, nationwide cohort study using administrative registry data.
Study drug and medical condition

Name of medicine

ELIQUIS
LIXIANA
PRADAXA
XARELTO

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

WARFARIN

Medical condition to be studied

Deep vein thrombosis
Pulmonary embolism
Population studied

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

20000
Study design details

Main study objective

Phase I involves a descriptive assessment of patient characteristics and treatment patterns in each country as well as detailed power calculations. If the study is adequately powered for comparative analyses, it will proceed to Phase II. Phase II involves analyses of comparative effectiveness and safety, utilising warfarin as the comparator.

Outcomes

Primary efficacy, Recurrent VTE Primary safety, Major Bleeding, Treatment interruption, Complete treatment discontinuation, Treatment switching, Treatment persistence, GI bleeding, intracranial haemorrhage, other bleeding, health care resource utilisation

Data analysis plan

Phase I of this study would be descriptive in nature, including the number, percentage of patients who discontinue, interrupt, and switch treatment. Patient characteristics will be summarised using numbers and percentages for categorical values and descriptive statistics (mean, SD, median, minimum, maximum and IQR) for continuous. Descriptive analyses will also be performed for specific subgroups. Phase II involves comparative safety and effectiveness analyses, which for this study includes a number of clinical endpoints (recurrent VTE, major bleeding, overall and by site (GI, ICH, other sites) and health care resource utilisation.