Hyperlipidemia
Conditions
Keywords
Pharmacological therapy
Brief summary
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.
Detailed description
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. The 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. For 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.
Interventions
Omega-3 fatty acid ethyl esters granular capsules
DRUGStandard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who meet all of the following criteria will be included in the survey: 1. Patients with hyperlipidemia on statin therapy 2. Outpatients 3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years 4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period) 5. Participants who have at least two of the following risk factors: * Hypertension * Type 2 diabetes mellitus * Chronic kidney disease * Prior history of myocardial infarction or angina pectoris * Prior history of cerebral infarction * Peripheral arterial disease
Exclusion criteria
-Participants who meet any of the following criteria will be excluded from the survey: 1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period 2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period 3. 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 4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) 5. Patients with malignant tumors currently under treatment 6. 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 7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) 8. 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) 9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Up to 36 months | 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. |
| Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Up to 36 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Up to 36 months | 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). |
| Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Up to 36 months | 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). |
| Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Up to 36 months | 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. |
| Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Up to 36 months | 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. |
| Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Up to 36 months | 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. |
| Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months fatty | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
| 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 | Up to 36 months | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 1076 investigative sites in Japan, from 21 October 2014 to 14 July 2020.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall 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. | 14,364 |
| Total | 14,364 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 564 |
| Overall Study | Protocol Deviation | 402 |
Baseline characteristics
| Characteristic | Overall | — |
|---|---|---|
| Age, Continuous | 70.8 Years STANDARD_DEVIATION 9.17 | — |
| BMI | 25.39 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.782 | — |
| Consumption of Triglyceride (TG) in 3 Month Prior to the Observation Period | 229.2 Milligram/deciliter (mg/dL) STANDARD_DEVIATION 101.98 | — |
| Drinking Habits Drink 5 days or more per week | 3645 Participants | — |
| Drinking Habits Drink less than 5 days per week or not drink | 10245 Participants | — |
| Family History of Cerebrovascular Disease (Parents, Brothers and Sisters) No family history | 11960 Participants | — |
| Family History of Cerebrovascular Disease (Parents, Brothers and Sisters) Positive family history | 1508 Participants | — |
| Family History of Coronary Artery Disease (Parents, Brothers and Sisters) No family history | 12307 Participants | — |
| Family History of Coronary Artery Disease (Parents, Brothers and Sisters) Positive family history | 1166 Participants | — |
| Frequency of Fish Consumption Almost everyday | 1234 Participants | — |
| Frequency of Fish Consumption Around once every other day | 4272 Participants | — |
| Frequency of Fish Consumption Around once or twice a week | 6838 Participants | — |
| Frequency of Fish Consumption Data not available | 1036 Participants | — |
| Frequency of Fish Consumption Rarely eat | 984 Participants | — |
| Frequency of Hospital Visit Around once a month | 9191 Participants | — |
| Frequency of Hospital Visit Less than once or twice every 3 months | 167 Participants | — |
| Frequency of Hospital Visit More than twice a month | 1410 Participants | — |
| Frequency of Hospital Visit Once or twice every 3 months | 3596 Participants | — |
| Frequency of Onset of Cerebral Hemorrhage before Study Start Data not available | 3 Participants | — |
| Frequency of Onset of Cerebral Hemorrhage before Study Start More than 3 times | 1 Participants | — |
| Frequency of Onset of Cerebral Hemorrhage before Study Start Once | 153 Participants | — |
| Frequency of Onset of Cerebral Hemorrhage before Study Start Twice | 10 Participants | — |
| Frequency of Onset of Cerebral Infarction before Study Start More than 3 times | 45 Participants | — |
| Frequency of Onset of Cerebral Infarction before Study Start Once | 2086 Participants | — |
| Frequency of Onset of Cerebral Infarction before Study Start Twice | 93 Participants | — |
| Frequency of Onset of Myocardial Infarction before Study Start More than 3 times | 12 Participants | — |
| Frequency of Onset of Myocardial Infarction before Study Start Once | 1202 Participants | — |
| Frequency of Onset of Myocardial Infarction before Study Start Twice | 47 Participants | — |
| Frequency of Onset of Subarachnoid Hemorrhage before Study Start More than 3 times | 0 Participants | — |
| Frequency of Onset of Subarachnoid Hemorrhage before Study Start Once | 44 Participants | — |
| Frequency of Onset of Subarachnoid Hemorrhage before Study Start Twice | 0 Participants | — |
| History and Complications of Cerebro-cardiovascular Disorder Absence | 2293 Participants | — |
| History and Complications of Cerebro-cardiovascular Disorder Presence | 11947 Participants | — |
| History of Peripheral Arterial Intervention Not received | 14207 Participants | — |
| History of Peripheral Arterial Intervention Received | 157 Participants | — |
| Number of Participants Who Underwent Coronary Revascularization Not received | 12463 Participants | — |
| Number of Participants Who Underwent Coronary Revascularization Received | 1901 Participants | — |
| Number of Risk Factors 2 | 9749 Participants | — |
| Number of Risk Factors 3 | 3532 Participants | — |
| Number of Risk Factors 4 | 919 Participants | — |
| Number of Risk Factors 5 | 150 Participants | — |
| Number of Risk Factors 6 | 14 Participants | — |
| Onset Time of Cerebral Hemorrhage before Study Start Less than 1 year | 8 Participants | — |
| Onset Time of Cerebral Hemorrhage before Study Start More than 1 year ago | 159 Participants | — |
| Onset Time of Cerebral Infarction before Study Start Less than 1 year | 199 Participants | — |
| Onset Time of Cerebral Infarction before Study Start More than 1 year ago | 2025 Participants | — |
| Onset Time of Myocardial Infarction before Study Start Less than 1 year | 102 Participants | — |
| Onset Time of Myocardial Infarction before Study Start More than 1 year ago | 1159 Participants | — |
| Onset Time of Subarachnoid Hemorrhage before Study Start Less than 1 year | 3 Participants | — |
| Onset Time of Subarachnoid Hemorrhage before Study Start More than 1 year ago | 41 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 14364 Participants | — |
| Sex: Female, Male Female | 6499 Participants | — |
| Sex: Female, Male Male | 7865 Participants | — |
| Smoking Classification Current Smoker | 1825 Participants | — |
| Smoking Classification Ex-Smoker | 4467 Participants | — |
| Smoking Classification Never Smoked | 7574 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 74 / 5,859 |
| other Total, other adverse events | 25 / 6,867 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 12 months | 1.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 18 months | 1.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 24 months | 1.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 30 months | 2.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 6 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 36 months | 2.5 Percentage of participants |
Primary
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 18 months | 1.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 24 months | 1.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 6 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 12 months | 1.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 30 months | 2.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 36 months | 2.7 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 6 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 12 months | 1.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 18 months | 1.8 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 24 months | 2.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 30 months | 2.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 36 months | 3.1 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 6 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 12 months | 1.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 18 months | 2.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 24 months | 2.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 30 months | 3.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 36 months | 3.6 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 1.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 1.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.9 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 1.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 1.4 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 1.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.8 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 1.2 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.8 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.9 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 1.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 1.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 1.4 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.8 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 1.1 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.7 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.2 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 30 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 36 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 12 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 18 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 24 months | 0.4 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 12 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 18 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 24 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 30 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 36 months | 0.7 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.3 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.3 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.5 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 6 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 12 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 18 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 24 months | 0.4 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 30 months | 0.5 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 36 months | 0.5 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.2 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.1 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.2 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months fatty
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.1 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.1 Percentage of participants |
Secondary
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
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.
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 6 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 12 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 18 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 24 months | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 30 months | 0.1 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | 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 | 36 months | 0.1 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
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).
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 24 months | 1.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 6 months | 0.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 12 months | 0.6 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 18 months | 0.8 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 30 months | 1.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User | 36 months | 1.4 Percentage of participants |
Secondary
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
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).
Time frame: Up to 36 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | Start of observation | 0.0 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 6 months | 0.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 12 months | 0.7 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 18 months | 0.9 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 24 months | 1.2 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 30 months | 1.3 Percentage of participants |
| Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g | Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User | 36 months | 1.5 Percentage of participants |