Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-17 @ 4:37 PM
Study NCT ID:
NCT02943993
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '908-992-6400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events were not assessed in this non-interventional (observational) study.', 'description': 'Treatment-emergent adverse events were not assessed in this non-interventional (observational) study. Adverse drug reactions were reported as a secondary outcome measure.', 'eventGroups': [{'id': 'EG000', 'title': 'ETNA-VTE', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2644, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 98, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.09', 'upperLimit': '4.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.', 'unitOfMeasure': 'Percentage of VTE recurrence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'VTE recurrence was assessed in the Full Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Participants with any bleeding events', 'categories': [{'measurements': [{'value': '304', 'groupId': 'OG000', 'lowerLimit': '10.31', 'upperLimit': '12.78'}]}]}, {'title': 'At least 1 major bleeding event', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.92'}]}]}, {'title': 'Clinically relevant non-major bleeding event', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal bleeding event', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Epidural or subdural haematoma bleeding event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Intra-ocular bleeding event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Intra-articular bleeding event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pleural bleeding event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other bleeding event', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}]}]}, {'title': 'Spontaneous bleeding', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}, {'title': 'Provoked bleeding', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Unknown bleeding', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of participants with bleeding events.\n\nFor the analysis of bleeding events, absolute number of participants were calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Bleeding events were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Recurrent DVT only', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': '2.95'}]}]}, {'title': 'Recurrent PE with DVT', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.54'}]}]}, {'title': 'Recurrent PE only', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.66'}]}]}, {'title': 'All-cause death', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.92', 'upperLimit': '4.37'}]}]}, {'title': 'Cardiovascular-related death', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '1.30'}]}]}, {'title': 'Venous thromboembolism-related death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.21'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.44'}]}]}, {'title': 'Systemic embolic event', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.27'}]}]}, {'title': 'Hospitalization related to CV', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.47', 'upperLimit': '10.75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.', 'unitOfMeasure': 'Percentage of real world safety events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Real word safety events were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Recurrent VTE', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.92'}]}]}, {'title': 'Recurrent DVT only', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.48'}]}]}, {'title': 'Recurrent PE with DVT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.21'}]}]}, {'title': 'Recurrent PE only', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.65'}]}]}, {'title': 'All-cause death', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '2.49'}]}]}, {'title': 'CV-related death', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.74'}]}]}, {'title': 'VTE-related death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.21'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '0.93'}]}]}, {'title': 'Systemic embolic event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.21'}]}]}, {'title': 'Hospitalization-related to cardiovascular', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.42', 'upperLimit': '7.31'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.', 'unitOfMeasure': 'Percentage of VTE recurrence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'VTE recurrence was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Total Number of Venous Thromboembolism Recurrences By Type - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Total number of VTE recurrences', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Deep vein thrombosis (DVT) only', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary embolism with DVT', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary embolism only', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to describe the number of VTE events reported by the patient.\n\nFor VTE recurrences, absolute number of VTE events were calculated.', 'unitOfMeasure': 'VTE recurrences', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of VTE recurrences were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of Venous Thromboembolism Recurrences, by Type - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Total number of VTE recurrences', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '93.0'}]}]}, {'title': 'Deep vein thrombosis (DVT) only', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '95.0'}]}]}, {'title': 'Pulmonary embolism with DVT', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '146.0'}]}]}, {'title': 'Pulmonary embolism only', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '93.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the duration of VTE events reported by the patient.\n\nFor VTE recurrences, median duration of VTE events (interquartile range) were calculated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Total number of VTE recurrences', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Deep vein thrombosis (DVT) only', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary embolism with DVT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary embolism only', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient.\n\nFor VTE recurrences, absolute number of VTE recurrences were calculated.', 'unitOfMeasure': 'VTE recurrences', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of VTE recurrences were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of Venous Thromboembolism Events (On Edoxaban Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Total number of VTE recurrences', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '20.0'}]}]}, {'title': 'Deep vein thrombosis (DVT) only', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '20'}]}]}, {'title': 'Pulmonary embolism with DVT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pulmonary embolism only', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '16.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the duration of VTE events reported by the patient.\n\nFor VTE events, median duration of VTE events (interquartile range) were calculated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Risk Factors for Thromboembolic Events at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Puerperium', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Prolonged immobilisation', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}]}]}, {'title': '>5 days in bed', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}, {'title': 'History of major surgery trauma', 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}]}]}, {'title': 'Known thrombophilic conditions', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Baseline', 'description': 'Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events.\n\nFor risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Risk factors were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of Edoxaban Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Month 1 ongoing', 'categories': [{'measurements': [{'value': '2527', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 ongoing', 'categories': [{'measurements': [{'value': '2346', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 ongoing', 'categories': [{'measurements': [{'value': '1842', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 ongoing', 'categories': [{'measurements': [{'value': '1272', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 ongoing', 'categories': [{'measurements': [{'value': '713', 'groupId': 'OG000'}]}]}, {'title': 'Participants off edoxaban treatment at 18 months', 'categories': [{'measurements': [{'value': '1910', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of observational period (18 months)', 'description': 'Descriptive statistics were used to report the duration of edoxaban treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of edoxaban treatment was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Stroke Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Overall treatment: Total number of stroke events', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment: Ischemic events', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment: Haemorrhagic events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment: Unknown events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'On treatment: Total number of stroke events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'On treatment: Ischemic events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'On treatment: Haemorrhagic events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'On treatment: Unknown events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of stroke events.\n\nFor stroke events, absolute number of stroke events were calculated.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Stroke events were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Systemic Embolic Events - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Upper/lower extremity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of systemic embolic events (SEE).\n\nFor SEE, absolute SEEs were calculated.', 'unitOfMeasure': 'Systemic embolic events', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic embolic events were assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Overview of Participants With Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2655', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Death due to ADR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Participants with at least 1 ADR', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}, {'title': 'Participants with at least 1 serious ADR', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Study discontinuation due to ADR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse drug reactions were assessed in the Baseline Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2655', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Haemorrhage', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal haemorrhage', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Menorrhagia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of observational period (18 months)', 'description': 'Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse drug reactions were assessed in the Baseline Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pre-defined Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2655', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'classes': [{'title': 'Stroke', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Bleeding events', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Systemic embolic events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-valvular atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Malignancy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse drug reactions were assessed in the Baseline Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ETNA-VTE', 'description': 'Participants with established initial or recurrent acute symptomatic venous thromboembolism (VTE) who were treated with edoxaban according to the Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Disposition data are based on Baseline Analysis Set (BAS) defined as All-Documented Patient Set participants with any documentation at the Baseline data collection point who fulfil the BAS criteria.', 'groupId': 'FG000', 'numSubjects': '2655'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2644'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2325'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'Transfer to another institution', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '135'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'Other reason for premature termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Missing reason for termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ETNA-VTE', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'BG000', 'lowerLimit': '52.0', 'upperLimit': '76.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1312', 'groupId': 'BG000'}]}]}, {'title': '≥65 and <75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '593', 'groupId': 'BG000'}]}]}, {'title': '≥75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '739', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1231', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1413', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '722', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '372', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '321', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}, {'title': 'Ireland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2644', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '833', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Demographic and baseline characteristics were assessed in the Full Analysis Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-12', 'size': 2800465, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-16T08:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2809}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2016-10-24', 'resultsFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-18', 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.'}, {'measure': 'Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of participants with bleeding events.\n\nFor the analysis of bleeding events, absolute number of participants were calculated.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.'}, {'measure': 'Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.\n\nFor symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.'}, {'measure': 'Total Number of Venous Thromboembolism Recurrences By Type - Overall', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to describe the number of VTE events reported by the patient.\n\nFor VTE recurrences, absolute number of VTE events were calculated.'}, {'measure': 'Duration of Venous Thromboembolism Recurrences, by Type - Overall', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the duration of VTE events reported by the patient.\n\nFor VTE recurrences, median duration of VTE events (interquartile range) were calculated.'}, {'measure': 'Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient.\n\nFor VTE recurrences, absolute number of VTE recurrences were calculated.'}, {'measure': 'Duration of Venous Thromboembolism Events (On Edoxaban Treatment)', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to assess the duration of VTE events reported by the patient.\n\nFor VTE events, median duration of VTE events (interquartile range) were calculated.'}, {'measure': 'Number of Participants With Risk Factors for Thromboembolic Events at Baseline', 'timeFrame': 'at Baseline', 'description': 'Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events.\n\nFor risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.'}, {'measure': 'Duration of Edoxaban Treatment', 'timeFrame': 'Baseline up to end of observational period (18 months)', 'description': 'Descriptive statistics were used to report the duration of edoxaban treatment.'}, {'measure': 'Number of Stroke Events', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of stroke events.\n\nFor stroke events, absolute number of stroke events were calculated.'}, {'measure': 'Number of Systemic Embolic Events - Overall', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': 'Descriptive statistics were used to report the number of systemic embolic events (SEE).\n\nFor SEE, absolute SEEs were calculated.'}, {'measure': 'Overview of Participants With Adverse Drug Reactions', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.'}, {'measure': 'Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)', 'timeFrame': 'Baseline up to end of observational period (18 months)', 'description': 'Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.'}, {'measure': 'Number of Participants With Pre-defined Adverse Drug Reactions', 'timeFrame': 'Baseline up to end of observation period (18 months)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post-Authorisation Safety Study', 'Real World Evidence', 'Edoxaban', 'Efficacy/Safety'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '24251359', 'type': 'BACKGROUND', 'citation': 'Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.'}, {'pmid': '23991658', 'type': 'BACKGROUND', 'citation': 'Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.'}, {'pmid': '32826158', 'type': 'DERIVED', 'citation': 'Cohen AT, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Bruggenjurgen B, Levy P, Laeis P, Fronk EM, Zierhut W, Malzer T, Manu MC, Reimitz PE, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries. Eur J Intern Med. 2020 Dec;82:48-55. doi: 10.1016/j.ejim.2020.08.014. Epub 2020 Aug 18.'}, {'pmid': '29719492', 'type': 'DERIVED', 'citation': 'Cohen AT, Ay C, Hainaut P, Decousus H, Hoffmann U, Gaine S, Coppens M, da Silva PM, Castro DJ, Amann-Vesti B, Bruggenjurgen B, Levy P, Bastida JL, Vicaut E, Laeis P, Fronk EM, Zierhut W, Malzer T, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study. Thromb J. 2018 May 1;16:9. doi: 10.1186/s12959-018-0163-7. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nTherefore, 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.', 'detailedDescription': '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.\n\nPatients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients with established initial or recurrent acute symptomatic VTE (distal or proximal deep vein thrombosis/pulmonary embolism) treated with edoxaban according to the Summary of Product Characteristics (SmPC). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established acute initial or recurrent VTE\n* Clinical decision for treatment with edoxaban is made at the time of enrollment\n* Written informed consent for participation in the study (ICF)\n* Not simultaneously participating in any interventional study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02943993', 'acronym': 'ETNA-VTE', 'briefTitle': 'Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe', 'orgStudyIdInfo': {'id': 'DSE-EDO-05-14-EU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Edoxaban', 'description': "Patients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.", 'interventionNames': ['Drug: Edoxaban']}], 'interventions': [{'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Lixiana'], 'description': 'Prescribed according to approved label', 'armGroupLabels': ['Patients treated with Edoxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82110', 'city': 'Germering', 'country': 'Germany', 'facility': 'International Clinical Research GmbH', 'geoPoint': {'lat': 48.13392, 'lon': 11.3765}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}