Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine

ELIQUIS
Population studied

Short description of the study population

Health care professionals (HCPs) using and adult patients receiving Eliquis® (apixaban).

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

576
Study design details

Main study objective

The primary objective of this study is to evaluate the effectiveness of the Eliquis Prescriber Guide and Patient Alert Card in terms of knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.

Outcomes

The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment. (1) The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the RM tools, (2) The proportions of HCPs using Eliquis and patients treated with Eliquis who have utilized the RM tools, and the extent of tool usage, and (3) The levels and distributions of behavior questionnaire results for HCPs and patients.

Data analysis plan

Descriptive analyses of the data will be conducted. HCP data will be presented by country, indication, specialty, HCP type, practice setting, regular vs. occasional treatment with Eliquis, RM tool users vs. non-users, and in total. Patient data will be presented by country, indication, duration of exposure, usage vs. non-usage of the Patient Alert Card, number of previous anticoagulant treatments prescribed, and in total.