Venous Thromboembolism
Conditions
Keywords
Post-Authorisation Safety Study, Real World Evidence, Edoxaban, Efficacy/Safety
Brief summary
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.
Detailed description
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.
Interventions
DRUGEdoxaban
Prescribed according to approved label
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established acute initial or recurrent VTE * Clinical decision for treatment with edoxaban is made at the time of enrollment * Written informed consent for participation in the study (ICF) * Not simultaneously participating in any interventional study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | Baseline up to end of observation period (18 months) | 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. |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Baseline up to end of observation period (18 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Venous Thromboembolism Recurrences By Type - Overall | Baseline up to end of observation period (18 months) | 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. |
| Duration of Venous Thromboembolism Recurrences, by Type - Overall | Baseline up to end of observation period (18 months) | 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. |
| Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | 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. |
| Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | 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. |
| Number of Participants With Risk Factors for Thromboembolic Events at Baseline | 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. |
| Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Baseline up to end of observation period (18 months) | 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. |
| Number of Stroke Events | Baseline up to end of observation period (18 months) | Descriptive statistics were used to report the number of stroke events. For stroke events, absolute number of stroke events were calculated. |
| Number of Systemic Embolic Events - Overall | Baseline up to end of observation period (18 months) | Descriptive statistics were used to report the number of systemic embolic events (SEE). For SEE, absolute SEEs were calculated. |
| Overview of Participants With Adverse Drug Reactions | Baseline up to end of observation period (18 months) | 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. |
| Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Baseline up to end of observational period (18 months) | Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1. |
| Number of Participants With Pre-defined Adverse Drug Reactions | Baseline up to end of observation period (18 months) | 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. |
| Duration of Edoxaban Treatment | Baseline up to end of observational period (18 months) | Descriptive statistics were used to report the duration of edoxaban treatment. |
| Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Baseline up to end of observation period (18 months) | 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. |
Countries
Germany
Participant flow
Recruitment details
A total of 2809 participants were included in the All Documented Patient Set defined as participants with a signed ICF and trustworthy data at sites in Germany, Austria, Switzerland, Belgium, The Netherlands, United Kingdom, Ireland, and Italy; a total of 2655 participants were included in the Baseline Analysis Set and a total of 2644 participants were included in the Full Analysis Set.
Participants by arm
| Arm | Count |
|---|---|
| ETNA-VTE Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician. | 2,644 |
| Total | 2,644 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 98 |
| Overall Study | Lost to Follow-up | 135 |
| Overall Study | Missing reason for termination | 7 |
| Overall Study | Other reason for premature termination | 32 |
| Overall Study | Transfer to another institution | 6 |
| Overall Study | Withdrawal by Subject | 52 |
Baseline characteristics
| Characteristic | ETNA-VTE | — |
|---|---|---|
| Age, Continuous | 65.0 years | — |
| Age, Customized ≥65 and <75 years | 593 Participants | — |
| Age, Customized <65 years | 1312 Participants | — |
| Age, Customized ≥75 years | 739 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 182 participants | — |
| Region of Enrollment Belgium | 372 participants | — |
| Region of Enrollment Germany | 722 participants | — |
| Region of Enrollment Ireland | 17 participants | — |
| Region of Enrollment Italy | 833 participants | — |
| Region of Enrollment Netherlands | 321 participants | — |
| Region of Enrollment Switzerland | 84 participants | — |
| Region of Enrollment United Kingdom | 113 participants | — |
| Sex: Female, Male Female | 1231 Participants | — |
| Sex: Female, Male Male | 1413 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 98 / 2,644 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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)
Population: Bleeding events were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Unknown bleeding | 18 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Participants with any bleeding events | 304 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | At least 1 major bleeding event | 38 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Clinically relevant non-major bleeding event | 82 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Minor | 300 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Gastrointestinal bleeding event | 77 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Epidural or subdural haematoma bleeding event | 4 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Intra-ocular bleeding event | 5 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Intra-articular bleeding event | 3 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Pleural bleeding event | 1 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Other bleeding event | 319 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Spontaneous bleeding | 287 participants |
| ETNA-VTE | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Provoked bleeding | 115 participants |
Primary
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)
Population: VTE recurrence was assessed in the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | 3.8 Percentage of VTE recurrence |
Secondary
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)
Population: Duration of edoxaban treatment was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETNA-VTE | Duration of Edoxaban Treatment | Month 1 ongoing | 2527 Participants |
| ETNA-VTE | Duration of Edoxaban Treatment | Month 3 ongoing | 2346 Participants |
| ETNA-VTE | Duration of Edoxaban Treatment | Month 6 ongoing | 1842 Participants |
| ETNA-VTE | Duration of Edoxaban Treatment | Month 12 ongoing | 1272 Participants |
| ETNA-VTE | Duration of Edoxaban Treatment | Month 18 ongoing | 713 Participants |
| ETNA-VTE | Duration of Edoxaban Treatment | Participants off edoxaban treatment at 18 months | 1910 Participants |
Secondary
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)
Population: Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ETNA-VTE | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Total number of VTE recurrences | 11.0 days |
| ETNA-VTE | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Deep vein thrombosis (DVT) only | 9.5 days |
| ETNA-VTE | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Pulmonary embolism with DVT | 0 days |
| ETNA-VTE | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Pulmonary embolism only | 15.0 days |
Secondary
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)
Population: Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ETNA-VTE | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Total number of VTE recurrences | 18.0 days |
| ETNA-VTE | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Deep vein thrombosis (DVT) only | 44.5 days |
| ETNA-VTE | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Pulmonary embolism with DVT | 8.0 days |
| ETNA-VTE | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Pulmonary embolism only | 16.0 days |
Secondary
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)
Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Haemorrhage | 35 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Gastrointestinal haemorrhage | 12 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Menorrhagia | 12 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Epistaxis | 11 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Fatigue | 8 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Nausea | 8 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Dizziness | 7 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Rash | 7 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Headache | 5 Participants |
| ETNA-VTE | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Pruritus | 5 Participants |
Secondary
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)
Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Stroke | 2 Participants |
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Bleeding events | 75 Participants |
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Systemic embolic events | 0 Participants |
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Non-valvular atrial fibrillation | 0 Participants |
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Malignancy | 0 Participants |
| ETNA-VTE | Number of Participants With Pre-defined Adverse Drug Reactions | Others | 4 Participants |
Secondary
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
Population: Risk factors were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETNA-VTE | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | Puerperium | 9 Participants |
| ETNA-VTE | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | Prolonged immobilisation | 401 Participants |
| ETNA-VTE | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | >5 days in bed | 218 Participants |
| ETNA-VTE | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | History of major surgery trauma | 359 Participants |
| ETNA-VTE | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | Known thrombophilic conditions | 111 Participants |
Secondary
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)
Population: Stroke events were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Number of Stroke Events | Overall treatment: Total number of stroke events | 27 events |
| ETNA-VTE | Number of Stroke Events | Overall treatment: Ischemic events | 17 events |
| ETNA-VTE | Number of Stroke Events | Overall treatment: Haemorrhagic events | 5 events |
| ETNA-VTE | Number of Stroke Events | Overall treatment: Unknown events | 5 events |
| ETNA-VTE | Number of Stroke Events | On treatment: Total number of stroke events | 16 events |
| ETNA-VTE | Number of Stroke Events | On treatment: Ischemic events | 12 events |
| ETNA-VTE | Number of Stroke Events | On treatment: Haemorrhagic events | 3 events |
| ETNA-VTE | Number of Stroke Events | On treatment: Unknown events | 1 events |
Secondary
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)
Population: Systemic embolic events were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Number of Systemic Embolic Events - Overall | Upper/lower extremity | 1 Systemic embolic events |
| ETNA-VTE | Number of Systemic Embolic Events - Overall | Renal | 1 Systemic embolic events |
Secondary
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)
Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETNA-VTE | Overview of Participants With Adverse Drug Reactions | Death due to ADR | 2 Participants |
| ETNA-VTE | Overview of Participants With Adverse Drug Reactions | Participants with at least 1 ADR | 142 Participants |
| ETNA-VTE | Overview of Participants With Adverse Drug Reactions | Participants with at least 1 serious ADR | 59 Participants |
| ETNA-VTE | Overview of Participants With Adverse Drug Reactions | Study discontinuation due to ADR | 0 Participants |
Secondary
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)
Population: Real word safety events were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Recurrent DVT only | 2.3 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Recurrent PE with DVT | 0.3 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Recurrent PE only | 1.2 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | All-cause death | 3.6 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Cardiovascular-related death | 0.9 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Venous thromboembolism-related death | 0 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Stroke | 1.0 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Systemic embolic event | 0.1 Percentage of real world safety events |
| ETNA-VTE | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Hospitalization related to CV | 9.6 Percentage of real world safety events |
Secondary
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)
Population: VTE recurrence was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Recurrent VTE | 1.4 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Recurrent DVT only | 1.0 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Recurrent PE with DVT | 0 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Recurrent PE only | 0.3 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | All-cause death | 1.9 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | CV-related death | 0.4 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | VTE-related death | 0 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Stroke | 0.6 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Systemic embolic event | 0 Percentage of VTE recurrence |
| ETNA-VTE | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Hospitalization-related to cardiovascular | 6.3 Percentage of VTE recurrence |
Secondary
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)
Population: Number of VTE recurrences were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Total number of VTE recurrences | 105 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Deep vein thrombosis (DVT) only | 64 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Pulmonary embolism with DVT | 7 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Pulmonary embolism only | 32 VTE recurrences |
Secondary
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)
Population: Number of VTE recurrences were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Total number of VTE recurrences | 39 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Deep vein thrombosis (DVT) only | 28 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Pulmonary embolism with DVT | 1 VTE recurrences |
| ETNA-VTE | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Pulmonary embolism only | 9 VTE recurrences |