According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15). Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.
Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country. Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.
Study Type
OBSERVATIONAL
Enrollment
2,809
Prescribed according to approved label
International Clinical Research GmbH
Germering, Germany
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
Time frame: Baseline up to end of observation period (18 months)
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Descriptive statistics were used to report the number of participants with bleeding events. For the analysis of bleeding events, absolute number of participants were calculated.
Time frame: Baseline up to end of observation period (18 months)
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Descriptive statistics were used to report the number of participants experiencing recurrent VTE and at least 1 real world safety event. VTE recurrence data were reported by recurrent deep vein thrombosis (DVT), recurrent pulmonary embolism (PE) with DVT, and recurrent PE only. Recurrent VTE events were based on adjudicated events. Real world safety events included all-cause death, cardiovascular (CV)-related death, VTE-related death, stroke, systemic embolic event, and hospitalization related to CV. For recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.
Time frame: Baseline up to end of observation period (18 months)
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Descriptive statistics were used to report the number of participants with overall symptomatic VTE recurrence. VTE recurrence data were further reported by recurrent deep venous thrombosis (DVT), recurrent pulmonary embolism (PE) with deep venous thrombosis (DVT), and recurrent PE only. Recurrent VTE events were based on adjudicated events. For symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.
Time frame: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Descriptive statistics were used to describe the number of VTE events reported by the patient. For VTE recurrences, absolute number of VTE events were calculated.
Time frame: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Descriptive statistics were used to assess the duration of VTE events reported by the patient. For VTE recurrences, median duration of VTE events (interquartile range) were calculated.
Time frame: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient. For VTE recurrences, absolute number of VTE recurrences were calculated.
Time frame: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Descriptive statistics were used to assess the duration of VTE events reported by the patient. For VTE events, median duration of VTE events (interquartile range) were calculated.
Time frame: Baseline up to end of observation period (18 months)
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events. For risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.
Time frame: at Baseline
Duration of Edoxaban Treatment
Descriptive statistics were used to report the duration of edoxaban treatment.
Time frame: Baseline up to end of observational period (18 months)
Number of Stroke Events
Descriptive statistics were used to report the number of stroke events. For stroke events, absolute number of stroke events were calculated.
Time frame: Baseline up to end of observation period (18 months)
Number of Systemic Embolic Events - Overall
Descriptive statistics were used to report the number of systemic embolic events (SEE). For SEE, absolute SEEs were calculated.
Time frame: Baseline up to end of observation period (18 months)
Overview of Participants With Adverse Drug Reactions
Descriptive statistics were used to report an overview of participants with adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Time frame: Baseline up to end of observation period (18 months)
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Time frame: Baseline up to end of observational period (18 months)
Number of Participants With Pre-defined Adverse Drug Reactions
Descriptive statistics were used to report the number of participants with pre-defined adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Time frame: Baseline up to end of observation period (18 months)
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