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On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:
A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective Observational | Other | this is an observational study non interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population | 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. | Baseline |
| Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population | 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. | Baseline |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population | Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant. | Month 3 |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | Month 6 |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | Month 9 |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reason for Increased or Decreased Eplerenone Dose | Baseline up to Month 12 | |
| Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Other Notable Events in FAS Population | 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.). |
Inclusion Criteria:
The following patients may be selected to participate in the survey:
Exclusion Criteria:
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The following patients may be selected to participate in the survey:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Out of a total of 160 participants, data for baseline measure (age) was available for only 159 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of EDV | Baseline |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. |
| Month 12 |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | 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. | Baseline, Month 3 |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | 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. | Baseline, Month 6 |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | 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. | Baseline, Month 9 |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | 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. | Baseline, Month 12 |
| Percentage of Participants Who Died in SAS Population | Baseline up to Month 12 |
| Percentage of Participants Hospitalized in FAS Population | Baseline up to Month 12 |
| Number of Participants With Worsened Renal Function | Baseline up to Month 12 |
| Baseline up to Month 12 |
| Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | Baseline up to Month 12 |
| Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population | Baseline up to Month 12 |
| Baseline up to Month 12 |
| Percentage of Participants With General Practitioner (GP) Consultation in FAS Population | Baseline up to Month 12 |
| Number of Measurements Per Month for Kalaemia Levels in FAS Population | 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. | Months 3, 6, 9, 12 |
| Maximum Kalaemia Levels in Serum in FAS Population | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. | Baseline up to Month 12 |
| Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | 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. | Baseline up to Month 12 |
| Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | 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. | Baseline, Months 3, 6, 9, 12 |
| Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | 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. | Baseline |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of EDV | Baseline |
|
|
|
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population | Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 3 |
|
|
|
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 9 |
|
|
|
| Primary | Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | 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. | FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Month 3 |
|
|
|
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Month 6 |
|
|
|
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Month 9 |
|
|
|
| Primary | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Month 12 |
|
|
|
| Primary | Percentage of Participants Who Died in SAS Population | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Month 12 |
|
|
|
| Primary | Percentage of Participants Hospitalized in FAS Population | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Month 12 |
|
|
|
| Primary | Number of Participants With Worsened Renal Function | Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study. | Posted | Baseline up to Month 12 |
|
|
| Secondary | Number of Participants With Reason for Increased or Decreased Eplerenone Dose | Data were not statistically summarized and were provided in individual participant listings as per the planned analysis. | Posted | Baseline up to Month 12 |
|
|
| Secondary | Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | 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. | Posted | Number | Participants | Baseline up to Month 12 |
|
|
|
| Secondary | Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. | SAS population included all participants who received study medication. | Posted | Number | Participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population | FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Month 12 |
|
|
|
| Other Pre-specified | Percentage of Participants With Other Notable Events in FAS Population | 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.). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Month 12 |
|
|
|
| Other Pre-specified | Percentage of Participants With General Practitioner (GP) Consultation in FAS Population | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Month 12 |
|
|
|
| Other Pre-specified | Number of Measurements Per Month for Kalaemia Levels in FAS Population | 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. | 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. | Posted | Mean | Standard Deviation | Measurements per month | Months 3, 6, 9, 12 |
|
|
|
| Other Pre-specified | Maximum Kalaemia Levels in Serum in FAS Population | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline up to Month 12 |
|
|
|
| Other Pre-specified | Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | 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. | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline up to Month 12 |
|
|
|
| Other Pre-specified | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | 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. | FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Months 3, 6, 9, 12 |
|
|
|
| Other Pre-specified | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | 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. | FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline |
|
|
|
| 17 |
| 160 |
| 20 |
| 160 |
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac flutter | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Missing code | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
| Endarterectomy | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
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.
|
| Baseline: 50 mg daily dose (n=148) |
|
| Change at Month 3: Decrease (n=89) |
|
| Change at Month 3: No change (n=89) |
|
| Change at Month 3: Increase (n=89) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 12 (n=70) |
|
|
| Baseline: Stage IV (n=148) |
|
| Month 3: Stage I (n=91) |
|
| Month 3: Stage II (n=91) |
|
| Month 3: Stage III (n=91) |
|
| Month 3: Stage IV (n=91) |
|
| Month 6: Stage I (n=71) |
|
| Month 6: Stage II (n=71) |
|
| Month 6: Stage III (n=71) |
|
| Month 6: Stage IV (n=71) |
|
| Month 9: Stage I (n=58) |
|
| Month 9: Stage II (n=58) |
|
| Month 9: Stage III (n=58) |
|
| Month 12: Stage I (n=70) |
|
| Month 12: Stage II (n=70) |
|
| Month 12: Stage III (n=70) |
|
| Title | Measurements |
|---|---|
|
| Myocardial infarction and heart failure |
|