Trial Outcomes & Findings for A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy (NCT NCT03415152)
NCT ID: NCT03415152
Last Updated: 2020-10-12
Results Overview
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Recruitment status
COMPLETED
Target enrollment
3000 participants
Primary outcome timeframe
6 months
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Overall Study
STARTED
|
3000
|
|
Overall Study
COMPLETED
|
1975
|
|
Overall Study
NOT COMPLETED
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1025
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Baseline characteristics by cohort
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1600 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
972 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1390 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2518 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
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Region of Enrollment
Russia
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2572 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Population of patients registered in electronic system and reported Omacor administration
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=180 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Mean Adherence Rate at the End of the Study (Visit 3)
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0.37 proportion of days
Standard Deviation 0.38
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Population of patients attended at Visit 3 (month 6)
The average score for the National questionnaire on therapy compliance for all study duration Visit 1 - Visit 3. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=1975 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3)
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12.9 score on a scale
Standard Deviation 2.99
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SECONDARY outcome
Timeframe: 6 monthsThe percentage of patients (%) who have chosen each of the suggested reason for therapy termination.
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Adverse drug reactions
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0 percentage of participants
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The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Lack of efficacy
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0.08 percentage of participants
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|
The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Inconvenience of use
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0.43 percentage of participants
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The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Absence at the pharmacy
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0.23 percentage of participants
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The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Other reason
|
1.94 percentage of participants
|
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The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Total
|
2.68 percentage of participants
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SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: Population of patients registered in electronic system and reported Omacor administration
Mean difference of the average score on each of 8 scales of Short Form Survey (SF)-36 quality of life questionnaire at Visit 2 and Visit 3 versus the baseline. 36-Item Short Form Survey (SF-36) taps eight health concepts. Each of 36 items is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state.
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=180 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Physical functioning (V2-V1,3 m)
|
7.63 score on a scale
Standard Deviation 13.4
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Role limitations due to physical health (V2-V1,3m)
|
32.86 score on a scale
Standard Deviation 48.42
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Role limitations due to emotional problems (V2-V1,
|
25.71 score on a scale
Standard Deviation 32.42
|
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Energy/fatique (V2-V1,3m)
|
20.81 score on a scale
Standard Deviation 14.12
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|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Emotional wellbeing (V2-V1,3m)
|
22.66 score on a scale
Standard Deviation 14.69
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Social functioning (V2-V1,3m)
|
26.43 score on a scale
Standard Deviation 25.68
|
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Pain (V2-V1,3m)
|
8.43 score on a scale
Standard Deviation 14.12
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
General health (V2-V1,3m)
|
-6.14 score on a scale
Standard Deviation 10.22
|
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The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Physical functioning (V3-V1,6m)
|
6.69 score on a scale
Standard Deviation 10.08
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Role limitations due to physical health (V3-V1,6m)
|
29.55 score on a scale
Standard Deviation 43.39
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Role limitations due to emotional problems (V3-V1,
|
18.18 score on a scale
Standard Deviation 30.39
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Energy/fatique (V3-V1,6m)
|
18.18 score on a scale
Standard Deviation 13.59
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Emotional wellbeing (V3-V1,6m)
|
25 score on a scale
Standard Deviation 14.56
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Social functioning (V3-V1,6m)
|
16.48 score on a scale
Standard Deviation 25.41
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Pain (V3-V1,6m)
|
0.11 score on a scale
Standard Deviation 0.53
|
|
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
General Health (V3-V1,6m)
|
-9.83 score on a scale
Standard Deviation 12.08
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SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: Per protocol population: patients who attended at least one follow-up visit.
Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1\)
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2167 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
total serum cholesterol (TSC) (V3-V1,6m)
|
-1.32 mmol/L
Standard Deviation 1.28
|
|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
total serum cholesterol (TSC) (V2-V1,3m)
|
-1 mmol/L
Standard Deviation 1.09
|
|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
triglycerides (TG) (V2-V1,3m)
|
-0.98 mmol/L
Standard Deviation 1
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|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
low-density lipoproteins (LDLP) (V2-V1,3m)
|
-0.77 mmol/L
Standard Deviation 0.92
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|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
high-density lipoproteins (HDLP) (V2-V1,3m)
|
0.15 mmol/L
Standard Deviation 0.45
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|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
triglycerides (TG) (V3-V1,6m)
|
-1.32 mmol/L
Standard Deviation 1.15
|
|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
low-density lipoproteins (LDLP) (V3-V1,6m)
|
-1.02 mmol/L
Standard Deviation 1.02
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|
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
high-density lipoproteins (HDLP) (V3-V1,6m)
|
0.2 mmol/L
Standard Deviation 0.53
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SECONDARY outcome
Timeframe: 6 monthsPercentage of patients with hospitalizations due to cardiovascular disease
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program
The presence of hospitalizations
|
0.74 percentage of participants
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|
Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program
The absence of hospitalizations
|
99.26 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of patients with new cases of stenocardia
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Number of New Cases of Stenocardia During 6 Months of the Program
The presence of new cases of angina pectoris
|
0.97 percentage of participants
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Number of New Cases of Stenocardia During 6 Months of the Program
The absence of new cases of angina pectoris
|
99.03 percentage of participants
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SECONDARY outcome
Timeframe: 6 monthsPercentage of patients with non-fatal myocardial infarction cases
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program
Presence of cases of non-fatal myocardial infarcti
|
0.04 percentage of participants
|
|
Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program
Absence of cases of nonfatal myocardial infarctio
|
99.96 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of patients dead due to cardio-vascular death
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2572 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Number of Cases of Cardio-vascular Death During 6 Months of the Program
|
0.04 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Population of patients registered in electronic system and reported Omacor administration
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=180 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Mean Adherence Rate at Visit 2
|
0.48 proportion of days
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: Population of patients registered in electronic system and reported Omacor administration
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=180 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2
|
0.24 proportion of days
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: Population of patients registered in electronic system and reported Omacor administration
The percentage of patients with adherence rate \<0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=180 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
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|---|---|
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The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Low (<0.5) (V2, 3 m)
|
50 percentage of participants
|
|
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Moderate (0.5 - 0.7) (V2, 3 m)
|
15.56 percentage of participants
|
|
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
High (≥0.8) (V2, 3 m)
|
34.44 percentage of participants
|
|
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Low (<0.5) (V3, 6 m)
|
75 percentage of participants
|
|
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Moderate (0.5 - 0.7) (V3, 6 m)
|
4.44 percentage of participants
|
|
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
High (≥0.8) (V3, 6 m)
|
20.56 percentage of participants
|
SECONDARY outcome
Timeframe: 0 months, 3 monthsPopulation: Per protocol population: patients who attended at least one follow-up visit
The average score for the National questionnaire on therapy compliance at Visit 1, Visit 2. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2167 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
|
|---|---|
|
Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2
Mean score (V 1, 0 m)
|
12.55 score on a scale
Standard Deviation 3.11
|
|
Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2
Mean score (V 2, 3 m)
|
12.99 score on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Baseline, 3 Months, 6 MonthsPopulation: Per protocol population: patients who attended at least one follow-up visit
The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Outcome measures
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=2167 Participants
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
|
|---|---|
|
Change of Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 Versus Baseline (Visit 1)
Mean difference (V 2-V 1, 3 m)
|
0.47 score on a scale
Standard Deviation 2.46
|
|
Change of Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 Versus Baseline (Visit 1)
Mean difference (V 3-V 1, 6 m)
|
0.44 score on a scale
Standard Deviation 2.52
|
Adverse Events
Omacor (Omega-3-acid Ethyl Esters)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omacor (Omega-3-acid Ethyl Esters)
n=3000 participants at risk
Adult patients who signed informed consent and were included in the program with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia and who have been prescribed Omacor for at least 6 months.
|
|---|---|
|
Gastrointestinal disorders
Eructation
|
0.03%
1/3000 • Number of events 1 • 6 months Adverse drug reactions, serious adverse drug reactions and other safety-related information are reported to sponsor from the inclusion of the patient in the program during Visit 1 until Visit 3.
Adverse drug reactions (ADR) but not adverse events (AE) were collected within the study. In the case of an ADR/SADR or other safety-related data, a physician must notify the sponsor contact person within 24 hours after getting acquainted with this information.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.03%
1/3000 • Number of events 1 • 6 months Adverse drug reactions, serious adverse drug reactions and other safety-related information are reported to sponsor from the inclusion of the patient in the program during Visit 1 until Visit 3.
Adverse drug reactions (ADR) but not adverse events (AE) were collected within the study. In the case of an ADR/SADR or other safety-related data, a physician must notify the sponsor contact person within 24 hours after getting acquainted with this information.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3000 • Number of events 1 • 6 months Adverse drug reactions, serious adverse drug reactions and other safety-related information are reported to sponsor from the inclusion of the patient in the program during Visit 1 until Visit 3.
Adverse drug reactions (ADR) but not adverse events (AE) were collected within the study. In the case of an ADR/SADR or other safety-related data, a physician must notify the sponsor contact person within 24 hours after getting acquainted with this information.
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3000 • Number of events 1 • 6 months Adverse drug reactions, serious adverse drug reactions and other safety-related information are reported to sponsor from the inclusion of the patient in the program during Visit 1 until Visit 3.
Adverse drug reactions (ADR) but not adverse events (AE) were collected within the study. In the case of an ADR/SADR or other safety-related data, a physician must notify the sponsor contact person within 24 hours after getting acquainted with this information.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place