Viewing Study NCT02584660

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Ignite Creation Date: 2025-12-25 @ 2:09 AM
Ignite Modification Date: 2026-01-22 @ 5:44 AM
Study NCT ID: NCT02584660
Status: COMPLETED
Last Update Posted: 2018-06-01
First Post: 2015-09-11
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Clinical Leader', 'organization': 'Janssen Scientific Affairs, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 2.5 years', 'description': 'The safety population included all randomized participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 15, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 13, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Systemic Inflammatory Response Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Embolic Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'May-Thurner Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Duration of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.191', 'spread': '0.6862', 'groupId': 'OG000'}, {'value': '1.393', 'spread': '1.9642', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.202', 'ciLowerLimit': '-1.730', 'ciUpperLimit': '-0.674', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 30', 'description': 'Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis set (ITT) included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'title': 'Up to 7 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 14 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 30 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 90 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7, 14, 30, and 90 Days', 'description': 'Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'title': 'Up to 7 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 14 Days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 30 Days', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Up to 90 Days', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7, 14, 30 and 90 Days', 'description': 'Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'title': 'Within 30 Days', 'categories': [{'measurements': [{'value': '0.679', 'spread': '2.0894', 'groupId': 'OG000'}, {'value': '1.513', 'spread': '1.9952', 'groupId': 'OG001'}]}]}, {'title': 'Within 90 Days', 'categories': [{'measurements': [{'value': '0.764', 'spread': '2.1829', 'groupId': 'OG000'}, {'value': '1.812', 'spread': '2.714', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 and 90 Days', 'description': 'Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'title': 'Item 1: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 1: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 1: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 1: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 1: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 2: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '70.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 2: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Item 2: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 2: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Item 2: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 3: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '65.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 3: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 3: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 3: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 3: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 4: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}]}]}, {'title': 'Item 4: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Item 4: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Item 4: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 4: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 5: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Item 5: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Item 5: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Item 5: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 5: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Item 6: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}, {'value': '56.4', 'groupId': 'OG001'}]}]}, {'title': 'Item 6: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 6: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 6: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Item 6: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Item 7: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 7: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '30.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 7: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Item 7: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 7: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 8: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000'}, {'value': '78.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 8: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Item 8: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 8: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 8: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Item 9: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 9: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 9: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 9: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 9: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Item 10: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 10: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Item 10: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 10: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 10: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 11: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Item 11: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Item 11: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 11: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Item 11: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 12: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}, {'value': '64.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 12: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 12: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 12: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Item 12: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Item 13: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 13: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 13: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 13: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 13: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 14: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 14: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 14: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Item 14: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 14: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 15: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 15: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 15: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}]}]}, {'title': 'Item 15: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 15: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 16: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 16: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Item 16: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Item 16: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Item 16: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '30.9', 'groupId': 'OG001'}]}]}, {'title': 'Item 17: Not at all', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 17: A little', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Item 17: Moderately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Item 17: Quite a bit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}, {'title': 'Item 17: Extremely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': "ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \\[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'OG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'classes': [{'title': 'Satisfaction level: Very Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction level: Quite Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction level: Neither', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction level: Quite Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction level: Very Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Location of care: Very Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'Location of care: Quite Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'Location of care: Neither', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Location of care: Quite Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Location of care: Very Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Preference of care: In the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}]}]}, {'title': 'Preference of care: In the Community', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}]}]}, {'title': 'Preference of care: No Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7', 'description': "The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who took at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'FG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of the 300 participants screened, 114 participants were randomized (51 to rivaroxaban group and 63 participants in the standard-of-care group) and 112 participants were treated and received at least 1 dose of study agent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivaroxaban', 'description': 'Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.'}, {'id': 'BG001', 'title': 'Standard-of-care', 'description': 'Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '13.27', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '17.22', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '15.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-16', 'size': 1194251, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-21T06:41', 'hasProtocol': True}, {'date': '2017-04-27', 'size': 657108, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-21T06:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2015-09-11', 'resultsFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2015-10-21', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-21', 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Duration of Hospitalization', 'timeFrame': 'Up to Day 30', 'description': 'Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death', 'timeFrame': 'Up to 7, 14, 30, and 90 Days', 'description': 'Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.'}, {'measure': 'Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding', 'timeFrame': 'Up to 7, 14, 30 and 90 Days', 'description': 'Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.'}, {'measure': 'Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason', 'timeFrame': 'Up to 30 and 90 Days', 'description': 'Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.'}, {'measure': 'Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)', 'timeFrame': 'Day 90', 'description': "ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \\[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment."}, {'measure': 'Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire', 'timeFrame': 'Day 7', 'description': "The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rivaroxaban', 'JNJ39039039', 'Pulmonary embolism'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.', 'detailedDescription': 'This is a randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, multicenter (study conducted at multiple sites) study to evaluate that low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments. Safety will be monitored during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic deep vein thrombosis (DVT)\n* A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low risk of clinical deterioration as determined by the Hestia criteria\n* Have no contraindications to and be able to complete randomized treatment and all study assessments\n* Have a life expectancy of at least 6 months\n* Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol\n\nExclusion Criteria:\n\n* Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450) inhibitors (such as but not limited to ketoconazole, telithromycin or protease inhibitors) use within 4 days before randomization, or planned use during the study. Itraconazole use within 7 days before randomization or planned use during the study\n* Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned use during the study\n* Who Has contraindications to the use of any anticoagulant therapy (example, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy documented at Screening)\n* Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients\n* Woman who is pregnant, or breast-feeding, or planning to become pregnant"}, 'identificationModule': {'nctId': 'NCT02584660', 'acronym': 'MERCURY PE', 'briefTitle': 'A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Scientific Affairs, LLC'}, 'officialTitle': 'MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department', 'orgStudyIdInfo': {'id': 'CR107694'}, 'secondaryIdInfos': [{'id': '39039039APE4001', 'type': 'OTHER', 'domain': 'Janssen Scientific Affairs, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban', 'description': 'Participants will receive Rivaroxaban 15 milligram (mg) orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food, for approximately 69 days for a total treatment duration of 90 days.', 'interventionNames': ['Drug: Rivaroxaban']}, {'type': 'EXPERIMENTAL', 'label': 'local Standard-of-care', 'description': 'Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.', 'interventionNames': ['Drug: Standard-of-care']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.', 'armGroupLabels': ['Rivaroxaban']}, {'name': 'Standard-of-care', 'type': 'DRUG', 'description': 'Standard-of-care as per local protocol and defined by the medical team caring for the participant.', 'armGroupLabels': ['local Standard-of-care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': 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