In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.
Patients will be from 10 different European countries and care settings (primary and secondary care and different specialties). A one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. Patient data will be documented at baseline (BL), one annual data documentation point during the four-year follow up (FU), and at final assessment. Patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first).
Study Type
OBSERVATIONAL
Enrollment
13,980
Prescribed according to approved label
Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years
Real-world safety data events include bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality
Time frame: within 4 years
Percentage of Participants with Patient Relevant Outcomes
Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a CV condition.
Time frame: within 4 years
Percentage of Participants Compliant with Edoxaban Therapy
Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
Time frame: over 4 years
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