Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02285166
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2014-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405603', 'term': 'Omacor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 36 months', 'description': 'In this survey, only the data of mortality and cardiovascular side effects with Omega-3 fatty acid ethyl esters 2 g (see Other Adverse Event\\[AE\\]s table below) were planned to be collected and report. That is, due to observational study, the other AEs data such as serious AEs, non-cardiovascular AEs were not planned to be collected and reported. Reported data were only mortality and side effects data in the population of treatment with Omega-3 fatty acid ethyl esters 2 g.', 'eventGroups': [{'id': 'EG000', 'title': 'Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care. Reported groups were combined in this section because group assignment (groups with or without intervention of omega-3 fatty acid ethyl esters) was conducted after completion of data collection (collection of Case Report Form) in this observational study and collection of data for each group during this study was not planned on the protocol of this study.', 'otherNumAtRisk': 6867, 'deathsNumAtRisk': 5859, 'otherNumAffected': 25, 'seriousNumAtRisk': 0, 'deathsNumAffected': 74, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6867, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 23.0'}], 'frequencyThreshold': '0.01'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death \\[including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death\\], non-fatal myocardial infarction, and non-fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), peripheral arterial disease requiring surgery or peripheral arterial intervention.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death \\[including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death\\], non-fatal myocardial infarction, and non-fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), peripheral arterial disease requiring surgery or peripheral arterial intervention.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. 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The efficacy analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7784', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Never User of Omega-3 Fatty Acid Ethyl Esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.'}], 'classes': [{'title': 'Start of observation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15330'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14364'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '966'}]}], 'dropWithdraws': [{'type': 'Case Report Forms Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '564'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '402'}]}]}], 'recruitmentDetails': 'Participants took part in the survey at 1076 investigative sites in Japan, from 21 October 2014 to 14 July 2020.', 'preAssignmentDetails': 'High-risk hyperlipidemic patients treated by statin in daily medical practice were enrolled. Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters as part of a routine medical care. Reported groups were combined because group assignment (With/Without intervention) was conducted after completion of data collection in this observational study and data collection for each group was not planned on the protocol of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.8', 'spread': '9.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6499', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7865', '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': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14364', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All participants were enrolled in Japan.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Risk Factors', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': '2', 'measurements': [{'value': '9749', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '3532', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '919', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': '6', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who had 2 or more risk factors at baseline was reported. Risk factors were categorized as follows; High blood pressure, Type 2 diabetes, Chronic kidney disease, History of myocardial infarction or angina, History of cerebral infarction, Peripheral artery disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Onset Time of Myocardial Infarction before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than 1 year', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'More than 1 year ago', 'measurements': [{'value': '1159', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.'}, {'title': 'Frequency of Onset of Myocardial Infarction before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Once', 'measurements': [{'value': '1202', 'groupId': 'BG000'}]}, {'title': 'Twice', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'More than 3 times', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.'}, {'title': 'Onset Time of Cerebral Infarction before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2224', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than 1 year', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}, {'title': 'More than 1 year ago', 'measurements': [{'value': '2025', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.'}, {'title': 'Frequency of Onset of Cerebral Infarction before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2224', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Once', 'measurements': [{'value': '2086', 'groupId': 'BG000'}]}, {'title': 'Twice', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'More than 3 times', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.'}, {'title': 'Number of Participants Who Underwent Coronary Revascularization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not received', 'measurements': [{'value': '12463', 'groupId': 'BG000'}]}, {'title': 'Received', 'measurements': [{'value': '1901', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Peripheral Arterial Intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not received', 'measurements': [{'value': '14207', 'groupId': 'BG000'}]}, {'title': 'Received', 'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12982', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.39', 'spread': '3.782', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'Kilogram (kg)/meter (m)^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13866', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '7574', 'groupId': 'BG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '1825', 'groupId': 'BG000'}]}, {'title': 'Ex-Smoker', 'measurements': [{'value': '4467', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Drinking Habits', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13890', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Drink 5 days or more per week', 'measurements': [{'value': '3645', 'groupId': 'BG000'}]}, {'title': 'Drink less than 5 days per week or not drink', 'measurements': [{'value': '10245', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Frequency of Hospital Visit', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': 'More than twice a month', 'measurements': [{'value': '1410', 'groupId': 'BG000'}]}, {'title': 'Around once a month', 'measurements': [{'value': '9191', 'groupId': 'BG000'}]}, {'title': 'Once or twice every 3 months', 'measurements': [{'value': '3596', 'groupId': 'BG000'}]}, {'title': 'Less than once or twice every 3 months', 'measurements': [{'value': '167', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Frequency of Fish Consumption', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Almost everyday', 'measurements': [{'value': '1234', 'groupId': 'BG000'}]}, {'title': 'Around once every other day', 'measurements': [{'value': '4272', 'groupId': 'BG000'}]}, {'title': 'Around once or twice a week', 'measurements': [{'value': '6838', 'groupId': 'BG000'}]}, {'title': 'Rarely eat', 'measurements': [{'value': '984', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '1036', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History and Complications of Cerebro-cardiovascular Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14240', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Presence', 'measurements': [{'value': '11947', 'groupId': 'BG000'}]}, {'title': 'Absence', 'measurements': [{'value': '2293', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Onset Time of Cerebral Hemorrhage before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than 1 year', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than 1 year ago', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.'}, {'title': 'Frequency of Onset of Cerebral Hemorrhage before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Once', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': 'Twice', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than 3 times', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Data not available', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.'}, {'title': 'Onset Time of Subarachnoid Hemorrhage before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Less than 1 year', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than 1 year ago', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.'}, {'title': 'Frequency of Onset of Subarachnoid Hemorrhage before Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Once', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Twice', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than 3 times', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.'}, {'title': 'Family History of Coronary Artery Disease (Parents, Brothers and Sisters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13473', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No family history', 'measurements': [{'value': '12307', 'groupId': 'BG000'}]}, {'title': 'Positive family history', 'measurements': [{'value': '1166', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Family History of Cerebrovascular Disease (Parents, Brothers and Sisters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13468', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No family history', 'measurements': [{'value': '11960', 'groupId': 'BG000'}]}, {'title': 'Positive family history', 'measurements': [{'value': '1508', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Consumption of Triglyceride (TG) in 3 Month Prior to the Observation Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14364', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '229.2', 'spread': '101.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram/deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Efficacy Analysis Set, The efficacy analysis set was defined as all participants who completed the survey. Reported groups were combined in this section because group assignment (groups with or without intervention of omega-3 fatty acid ethyl esters) was conducted after completion of data collection (collection of Case Report Form) in this observational study and collection of data for each group during this study was not planned on the protocol of this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-01', 'size': 1097907, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-13T05:35', 'hasProtocol': True}, {'date': '2020-08-20', 'size': 17754449, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-13T05:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2014-11-04', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-02', 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death \\[including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death\\], non-fatal myocardial infarction, and non-fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), peripheral arterial disease requiring surgery or peripheral arterial intervention.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death \\[including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death\\], non-fatal myocardial infarction, and non-fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), peripheral arterial disease requiring surgery or peripheral arterial intervention.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke \\[cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage\\] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data waspercentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization ) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User', 'timeFrame': 'Up to 36 months fatty', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.'}, {'measure': 'Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User', 'timeFrame': 'Up to 36 months', 'description': 'Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacological therapy'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '35772177', 'type': 'DERIVED', 'citation': 'Teramoto T, Ogawa H, Ueshima H, Okada Y, Haze K, Matsui S, Fujikawa K, Hashimoto T, Sakui S, Nishimura K, Kajita M, Horimoto A, Fernandez J. Effect of omega-3 fatty acids on cardiovascular events in high-risk patients with hypertriglyceridemia in Japan: a 3-year post-marketing surveillance study (OCEAN3 survey). Expert Opin Drug Saf. 2023 Jan;22(1):81-90. doi: 10.1080/14740338.2022.2094914. Epub 2022 Jul 8.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b60164db2bf003ab490aa', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.', 'detailedDescription': "This survey is planned to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.\n\nThe incidence rate of CV events in the participants who are treated by the standard anti-hyperlipidemic therapies other than omega-3 fatty acid ethyl esters is investigated in this survey so as to compare the events rates between two participant groups just for information.\n\nFor adults, 2 g of omega-3 fatty acid ethyl esters is usually administered orally once daily immediately after meals. However, the dose can be increased up to twice daily (to a dose of 2 g) depending on participant's triglyceride (TG) level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hyperlipidemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants who meet all of the following criteria will be included in the survey:\n\n1. Patients with hyperlipidemia on statin therapy\n2. Outpatients\n3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years\n4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)\n5. Participants who have at least two of the following risk factors:\n\n * Hypertension\n * Type 2 diabetes mellitus\n * Chronic kidney disease\n * Prior history of myocardial infarction or angina pectoris\n * Prior history of cerebral infarction\n * Peripheral arterial disease\n\nExclusion Criteria:\n\n-Participants who meet any of the following criteria will be excluded from the survey:\n\n1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period\n2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period\n3. Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period\n4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)\n5. Patients with malignant tumors currently under treatment\n6. Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period\n7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)\n8. Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)\n9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters'}, 'identificationModule': {'nctId': 'NCT02285166', 'briefTitle': 'Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Specified Drug-use Survey of Lotriga Granular Capsules: OCEAN3 (Outcome Prevention on Cardiovascular Events by Antihyperlipidemic Therapy With N3-fatty Acid in Japan)', 'orgStudyIdInfo': {'id': '142-012'}, 'secondaryIdInfos': [{'id': 'JapicCTI-142680', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ever User of Omega-3 fatty acid ethyl esters 2 g', 'description': 'The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.', 'interventionNames': ['Drug: Omega-3 fatty acid ethyl esters']}, {'label': 'Never User of Omega-3 fatty acid ethyl esters 2 g', 'description': 'Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.', 'interventionNames': ['Drug: Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).']}], 'interventions': [{'name': 'Omega-3 fatty acid ethyl esters', 'type': 'DRUG', 'otherNames': ['Lotriga granular capsules'], 'description': 'Omega-3 fatty acid ethyl esters granular capsules', 'armGroupLabels': ['Ever User of Omega-3 fatty acid ethyl esters 2 g']}, {'name': 'Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).', 'type': 'DRUG', 'armGroupLabels': ['Never User of Omega-3 fatty acid ethyl esters 2 g']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}