Trial · NCT02943993
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
NCT02943993, Completed, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company; results first posted 2022-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe. Trials, record NCT02943993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02943993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
- NCT number
- NCT02943993
- Status
- Completed
- Enrollment
- 2,809 participants, actual
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Conditions
- Venous Thromboembolism
- Interventions
- Edoxaban
- First posted
- 2016-10-25
- Last updated
- 2025-04-01
- Results first posted
- 2022-05-02
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Duration of Edoxaban Treatment | Baseline up to end of observational period (18 months) | Descriptive statistics were used to report the duration of edoxaban treatment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | Baseline up to end of observation period (18 months) | VTE recurrence was assessed in the Full Analysis Set. | Percentage of VTE recurrence | NUMBER |
| PRIMARY | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Baseline up to end of observation period (18 months) | Bleeding events were assessed in the Full Analysis Set. | participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Baseline up to end of observation period (18 months) | Real word safety events were assessed in the Full Analysis Set. | Percentage of real world safety events | NUMBER |
| SECONDARY | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Baseline up to end of observation period (18 months) | VTE recurrence was assessed in the Full Analysis Set. | Percentage of VTE recurrence | NUMBER |
| SECONDARY | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Baseline up to end of observation period (18 months) | Number of VTE recurrences were assessed in the Full Analysis Set. | VTE recurrences | NUMBER |
| SECONDARY | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Baseline up to end of observation period (18 months) | Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set. | days | MEDIAN |
| SECONDARY | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | Number of VTE recurrences were assessed in the Full Analysis Set. | VTE recurrences | NUMBER |
| SECONDARY | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set. | days | MEDIAN |
| SECONDARY | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | at Baseline | Risk factors were assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Edoxaban Treatment | Baseline up to end of observational period (18 months) | Duration of edoxaban treatment was assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | ETNA-VTE | 3.8 | 95% Confidence Interval 3.09 to 4.58 | Percentage of VTE recurrence | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Participants with any bleeding events | 304 | 10.31 to 12.78 | participants |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | At least 1 major bleeding event | 38 | 0.99 to 1.92 | participants |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Clinically relevant non-major bleeding event | 82 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Minor | 300 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Gastrointestinal bleeding event | 77 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Epidural or subdural haematoma bleeding event | 4 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Intra-ocular bleeding event | 5 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Intra-articular bleeding event | 3 | participants | |
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | ETNA-VTE | Pleural bleeding event | 1 | participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ETNA-VTE | 2,655 | |
| Overall Study | Full Analysis Set | ETNA-VTE | 2,644 | |
| Overall Study | COMPLETED | ETNA-VTE | 2,325 | |
| Overall Study | NOT COMPLETED | ETNA-VTE | 330 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETNA-VTE | 98 | 2,644 |
| Total, other adverse events | ETNA-VTE | 0 | 0 |
| Total, serious adverse events | ETNA-VTE | 0 | 0 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02943993
GET https://conductscience.org/api/trials/v1/NCT02943993/results?page=2