Trial Outcomes & Findings for Patient's Management Receiving Eplerenone Therapy (NCT NCT01440049)
NCT ID: NCT01440049
Last Updated: 2018-12-19
Results Overview
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
COMPLETED
160 participants
Baseline
2018-12-19
Participant Flow
Participant milestones
| Measure |
Eplerenone
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Overall Study
STARTED
|
160
|
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Overall Study
COMPLETED
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155
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Eplerenone
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Overall Study
Adverse Event
|
5
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Baseline Characteristics
Patient's Management Receiving Eplerenone Therapy
Baseline characteristics by cohort
| Measure |
Eplerenone
n=160 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Age, Continuous
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67.70 Years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
|
Sex: Female, Male
Female
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39 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Outcome measures
| Measure |
Eplerenone
n=127 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
|
41.2 Percentage of EDV
Standard Deviation 13.0
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PRIMARY outcome
Timeframe: BaselinePopulation: SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Outcome measures
| Measure |
Eplerenone
n=133 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
|
41.40 Percentage of EDV
Standard Deviation 12.82
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PRIMARY outcome
Timeframe: Month 3Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Outcome measures
| Measure |
Eplerenone
n=90 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
|
98.9 Percentage of participants
Interval 94.0 to 99.8
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PRIMARY outcome
Timeframe: Month 6Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Outcome measures
| Measure |
Eplerenone
n=71 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
|
95.8 Percentage of participants
Interval 88.3 to 98.6
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PRIMARY outcome
Timeframe: Month 9Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Outcome measures
| Measure |
Eplerenone
n=58 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
|
94.8 Percentage of participants
Interval 85.9 to 98.2
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PRIMARY outcome
Timeframe: Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Outcome measures
| Measure |
Eplerenone
n=70 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
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94.3 Percentage of participants
Interval 86.2 to 97.8
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PRIMARY outcome
Timeframe: Baseline, Month 3Population: FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Baseline: 10.7 mg daily dose (n=148)
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0.7 Percentage of participants
Interval 0.1 to 3.7
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Baseline: 12.5 mg daily dose (n=148)
|
3.4 Percentage of participants
Interval 1.5 to 7.7
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Baseline: 25 mg daily dose (n=148)
|
84.5 Percentage of participants
Interval 77.8 to 89.4
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Baseline: 50 mg daily dose (n=148)
|
11.5 Percentage of participants
Interval 7.3 to 17.6
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Change at Month 3: Decrease (n=89)
|
4.5 Percentage of participants
Interval 1.8 to 11.0
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Change at Month 3: No change (n=89)
|
76.4 Percentage of participants
Interval 66.6 to 84.0
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Change at Month 3: Increase (n=89)
|
19.1 Percentage of participants
Interval 12.3 to 28.5
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PRIMARY outcome
Timeframe: Baseline, Month 6Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Outcome measures
| Measure |
Eplerenone
n=68 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Decrease
|
5.9 Percentage of participants
Interval 2.3 to 14.2
|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
No change
|
70.6 Percentage of participants
Interval 58.9 to 80.1
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Increase
|
23.5 Percentage of participants
Interval 15.0 to 34.9
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PRIMARY outcome
Timeframe: Baseline, Month 9Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Outcome measures
| Measure |
Eplerenone
n=55 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Decrease
|
7.3 Percentage of participants
Interval 2.9 to 17.3
|
|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
No change
|
60.0 Percentage of participants
Interval 46.8 to 71.9
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|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Increase
|
32.7 Percentage of participants
Interval 21.8 to 45.9
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PRIMARY outcome
Timeframe: Baseline, Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Outcome measures
| Measure |
Eplerenone
n=66 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Decrease
|
6.1 Percentage of participants
Interval 2.4 to 14.6
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|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
No change
|
78.8 Percentage of participants
Interval 67.5 to 86.9
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|
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Increase
|
15.2 Percentage of participants
Interval 8.4 to 25.7
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PRIMARY outcome
Timeframe: Baseline up to Month 12Population: SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants Who Died in SAS Population
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6.1 Percentage of participants
Interval 3.2 to 11.2
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PRIMARY outcome
Timeframe: Baseline up to Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
Outcome measures
| Measure |
Eplerenone
n=146 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants Hospitalized in FAS Population
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22.6 Percentage of participants
Interval 16.6 to 30.0
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PRIMARY outcome
Timeframe: Baseline up to Month 12Population: Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
|
143 Participants
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SECONDARY outcome
Timeframe: Baseline up to Month 12Population: SAS population included all participants who received study medication.
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Outcome measures
| Measure |
Eplerenone
n=160 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
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144 Participants
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SECONDARY outcome
Timeframe: Baseline up to Month 12Population: FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Outcome measures
| Measure |
Eplerenone
n=143 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
|
13.3 Percentage of participants
Interval 8.7 to 19.8
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With Other Notable Events in FAS Population
|
18.9 Percentage of participants
Interval 13.4 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
|
77.7 Percentage of participants
Interval 70.3 to 83.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 3, 6, 9, 12Population: FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.
Outcome measures
| Measure |
Eplerenone
n=92 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
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|---|---|
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Number of Measurements Per Month for Kalaemia Levels in FAS Population
Month 3 (n=92)
|
0.5 Measurements per month
Standard Deviation 0.33
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Month 6 (n=71)
|
0.4 Measurements per month
Standard Deviation 0.27
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Month 9 (n=58)
|
0.3 Measurements per month
Standard Deviation 0.23
|
|
Number of Measurements Per Month for Kalaemia Levels in FAS Population
Month 12 (n=70)
|
0.2 Measurements per month
Standard Deviation 0.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Month 12Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.
Outcome measures
| Measure |
Eplerenone
n=127 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Maximum Kalaemia Levels in Serum in FAS Population
|
4.6 mmol/L
Standard Deviation 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Month 12Population: FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.
Outcome measures
| Measure |
Eplerenone
n=140 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
Baseline (n=140)
|
4.2 mmol/L
Standard Deviation 0.38
|
|
Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
Change in maximum Kalaemia level (n=123)
|
0.4 mmol/L
Standard Deviation 0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.
Outcome measures
| Measure |
Eplerenone
n=148 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Baseline: Stage I (n=148)
|
16.9 Percentage of participants
Interval 11.7 to 23.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Baseline: Stage II (n=148)
|
54.1 Percentage of participants
Interval 46.0 to 61.9
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Baseline: Stage III (n=148)
|
28.4 Percentage of participants
Interval 21.7 to 36.1
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Baseline: Stage IV (n=148)
|
0.7 Percentage of participants
Interval 0.1 to 3.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 3: Stage I (n=91)
|
29.7 Percentage of participants
Interval 21.3 to 39.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 3: Stage II (n=91)
|
61.5 Percentage of participants
Interval 51.3 to 70.9
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 3: Stage III (n=91)
|
6.6 Percentage of participants
Interval 3.1 to 13.6
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 3: Stage IV (n=91)
|
2.2 Percentage of participants
Interval 0.6 to 7.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 6: Stage I (n=71)
|
23.9 Percentage of participants
Interval 15.5 to 35.0
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 6: Stage II (n=71)
|
64.8 Percentage of participants
Interval 53.2 to 74.9
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 6: Stage III (n=71)
|
8.5 Percentage of participants
Interval 3.9 to 17.2
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 6: Stage IV (n=71)
|
2.8 Percentage of participants
Interval 0.8 to 9.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 9: Stage I (n=58)
|
22.4 Percentage of participants
Interval 13.6 to 34.7
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 9: Stage II (n=58)
|
65.5 Percentage of participants
Interval 52.7 to 76.4
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 9: Stage III (n=58)
|
12.1 Percentage of participants
Interval 6.0 to 22.9
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 12: Stage I (n=70)
|
27.1 Percentage of participants
Interval 18.1 to 38.5
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 12: Stage II (n=70)
|
64.3 Percentage of participants
Interval 52.6 to 74.5
|
|
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
Month 12: Stage III (n=70)
|
8.6 Percentage of participants
Interval 4.0 to 17.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.
Outcome measures
| Measure |
Eplerenone
n=147 Participants
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Myocardial infarction
|
61.9 Percentage of participants
Interval 53.8 to 69.4
|
|
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Heart failure
|
29.9 Percentage of participants
Interval 23.1 to 37.8
|
|
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
For another condition
|
4.8 Percentage of participants
Interval 2.3 to 9.5
|
|
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Myocardial infarction and heart failure
|
3.4 Percentage of participants
Interval 1.5 to 7.7
|
Adverse Events
Eplerenone
Serious adverse events
| Measure |
Eplerenone
n=160 participants at risk
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
3/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac flutter
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Death
|
1.2%
2/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Sudden death
|
1.2%
2/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Ejection fraction decreased
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
2/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Eplerenone
n=160 participants at risk
Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
2/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
1.9%
3/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Arteriogram coronary
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Missing code
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
3/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Endarterectomy
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.62%
1/160
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER