Impact Of Eplerenone On Cardiovascular Outcomes In Patien... | NCT01176968

ID	Type	Description	Link
2010-019844-38	EudraCT Number
REMINDER	Other Identifier	Alias Study Number

Label	Type	Description	Intervention Names
Eplerenone plus standard of care	Experimental		Drug: Eplerenone
Placebo plus standard of care	Placebo Comparator	Matching placebo for eplerenone 25mg film coated tablets.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone	Drug	Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.

Measure	Description	Time Frame
First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off	Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.	0-24 months

Measure	Description	Time Frame
Cardiovascular Mortality	The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta	T6G 2B7	Canada
Walter C Mackenzie Health Sciences Centre (WCM)

PubMed Identifier	Type	Citation	Retractions
24780614	Derived	Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
FG001	Placebo Plus Standard of Care

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

First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off

Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.

The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants	OG000506 OG001506

Title

Denominators

Categories

Title	Measurements
	OG00092 OG001149

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.	Regression, Cox		< 0.0001	All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.	Cox Proportional Hazard	0.581			2-Sided	95	0.446	0.756					Superiority or Other (legacy)

Secondary

Cardiovascular Mortality

The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

Diagnosis of Heart Failure

The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.

The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Secondary

First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).

The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).

The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Secondary

Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).

The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants

Secondary

Second or Subsequent Non-fatal Myocardial Infarction (MI).

The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.

Posted

Number

Events

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.

Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.

Posted

Mean

Standard Deviation

Milliseconds (msec)

6 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).

LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.

The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.

Posted

Mean

Standard Deviation

Centimeters (cm)

0-24 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants

Secondary

Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.

Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.

The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.

Posted

Median

Inter-Quartile Range

nmol/L

6 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts

Secondary

Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.

Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.

The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.

Posted

Median

Inter-Quartile Range

ng/mL

6 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants

Secondary

Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.

Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.

The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.

Posted

Median

Inter-Quartile Range

μg/L

6 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants

Secondary

Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.

Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.

The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.

Posted

Median

Inter-Quartile Range

pg/mL

6 months

ID	Title	Description
OG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
OG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0010 affected505 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0005 affected505 at risk EG0014 affected505 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG00012 affected505 at risk EG00110 affected505 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0004 affected505 at risk EG0019 affected505 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Atrial flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Cardiac asthma	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0003 affected505 at risk EG0019 affected505 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0014 affected505 at risk
Cardiac perforation	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0012 affected505 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0012 affected505 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0012 affected505 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Left ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Long QT syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0005 affected505 at risk EG0012 affected505 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Palpitations	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0010 affected505 at risk
Pericardial disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Pericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0003 affected505 at risk EG0012 affected505 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0013 affected505 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0011 affected505 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Photophobia	Eye disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment		EG0004 affected505 at risk EG0019 affected505 at risk
Death	General disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Device dislocation	General disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0012 affected505 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0012 affected505 at risk
Sudden death	General disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Cholecystitis infective	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Device related infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	Device related infection	EG0002 affected505 at risk EG0010 affected505 at risk
Gangrene	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0012 affected505 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0010 affected505 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0011 affected505 at risk
Joint hyperextension	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0010 affected505 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	Lung squamous cell carcinoma stage unspecified	EG0001 affected505 at risk EG0010 affected505 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Cerebral artery thrombosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	Cerebral artery thrombosis	EG0000 affected505 at risk EG0011 affected505 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0004 affected505 at risk EG0012 affected505 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0002 affected505 at risk EG0010 affected505 at risk
Dysarthria	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Lethargy	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Loss of consciousness	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Multiple system atrophy	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0003 affected505 at risk EG0014 affected505 at risk
Thoracic outlet syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Alcoholism	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Delirium	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Renal impairment	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	Urinary bladder haemorrhage	EG0000 affected505 at risk EG0011 affected505 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	Chronic obstructive pulmonary disease	EG0001 affected505 at risk EG0011 affected505 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	Idiopathic pulmonary fibrosis	EG0001 affected505 at risk EG0010 affected505 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	Implantable defibrillator insertion	EG0001 affected505 at risk EG0011 affected505 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	Inguinal hernia repair	EG0001 affected505 at risk EG0010 affected505 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	Percutaneous coronary intervention	EG0001 affected505 at risk EG0010 affected505 at risk
Circulatory collapse	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0012 affected505 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Infarction	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0000 affected505 at risk EG0011 affected505 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0011 affected505 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0001 affected505 at risk EG0010 affected505 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	Peripheral arterial occlusive disease	EG0003 affected505 at risk EG0012 affected505 at risk

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
BG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eplerenone Plus Standard of Care	Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.			100	505	151	506
EG001	Placebo Plus Standard of Care	Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.			101	505	153	506