Clinical Study Of Eplerenone In Japanese Patients With Ch... | NCT01115855

Label	Type	Description	Intervention Names
Eplerenone arm	Experimental	Add on standard heart failure therapy	Drug: Eplerenone
Placebo arm	Placebo Comparator	Add on standard heart failure therapy	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone	Drug	Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily	Eplerenone arm

Measure	Description	Time Frame
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)	CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.	Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

Measure	Description	Time Frame
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication	CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

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

Facility	Status	City	State	ZIP	Country	Contacts
Chubu Rosai Hospital		Nagoya	Aichi-ken	455-8530	Japan
Tosei General Hospital

PubMed Identifier	Type	Citation	Retractions
28824029	Derived	Tsutsui H, Ito H, Kitakaze M, Komuro I, Murohara T, Izumi T, Sunagawa K, Yasumura Y, Yano M, Yamamoto K, Yoshikawa T, Tsutamoto T, Zhang J, Okayama A, Ichikawa Y, Kanmuri K, Matsuzaki M; J-EMPHASIS-HF Study Group. Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF). Circ J. 2017 Dec 25;82(1):148-158. doi: 10.1253/circj.CJ-17-0323. Epub 2017 Aug 19.

ID	Title	Description
FG000	Eplerenone	Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.

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

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)

CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Units	Counts
Participants	OG000111 OG001110

Title

Denominators

Categories

Title	Measurements
	OG00033 OG00136

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	Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) covariates.					Hazard Ratio (HR)	0.85			2-Sided	95	0.53	1.36					Superiority or Other (legacy)

Secondary

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication

CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001

Secondary

Number of Participants With With First Occurrence of All-Cause Mortality

All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With With First Occurrence of Cardiovascular Mortality

CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of All-cause Hospitalization

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)

Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization

All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001

Secondary

Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization

HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization

CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening

Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke

Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)

Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter

New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of New Onset Diabetes Mellitus

New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function

Hospitalization due to worsening renal function (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With First Occurrence of Hospitalization for Hyperkalemia

Hospitalization due to hyperkalemia (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Full analysis set included all randomized participants.

Posted

Number

participants

Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

picogram/milliliter (pg/ml)

Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit

LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

percentage of LVEF

Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

microgram per gram creatinine (mg/gCr)

Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.

Secondary

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit

NYHA: classified as 'class I' (participants with cardiac disease but without resulting limitations of physical activity), 'class II' (participants with cardiac disease resulting in slight limitation of physical activity), 'class III' (participants with cardiac disease resulting in marked limitation of physical activity), 'class IV' (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as 'improved' (positive change), 'no change' or 'worsened' (negative change).

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Number

participants

Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo

Secondary

Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit

Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.

Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

metabolic equivalents (METs)

Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)

ID	Title	Description
OG000	Eplerenone	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
OG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0010 affected110 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0014 affected110 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0012 affected110 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG00027 affected111 at risk EG00131 affected110 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0011 affected110 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0012 affected110 at risk
Cardiac sarcoidosis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0012 affected110 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0011 affected110 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected111 at risk EG0013 affected110 at risk
Cataract	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0013 affected110 at risk
Retinal detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0012 affected110 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Protein-losing gastroenteropathy	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Chest discomfort	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0011 affected110 at risk
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Malaise	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Sudden cardiac death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0012 affected110 at risk
Sudden death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0013 affected110 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Device related infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected110 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0011 affected110 at risk
Influenza	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Peritonitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0004 affected111 at risk EG0015 affected110 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected110 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected111 at risk EG0010 affected110 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0010 affected110 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Blood pressure decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0012 affected110 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0012 affected110 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Oesophageal carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected111 at risk EG0012 affected110 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected111 at risk EG0011 affected110 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0013 affected110 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Extremity necrosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Haemorrhage	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected110 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected110 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected110 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment		EG0007 affected111 at risk EG0016 affected110 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment		EG00021 affected111 at risk EG00132 affected110 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0006 affected111 at risk EG0013 affected110 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0008 affected111 at risk EG00118 affected110 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0007 affected111 at risk EG00110 affected110 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0002 affected111 at risk EG0016 affected110 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment		EG0004 affected111 at risk EG0017 affected110 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment		EG0006 affected111 at risk EG0018 affected110 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment		EG0007 affected111 at risk EG0015 affected110 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment		EG00037 affected111 at risk EG00140 affected110 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment		EG0005 affected111 at risk EG0016 affected110 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment		EG00012 affected111 at risk EG0015 affected110 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment		EG00020 affected111 at risk EG00120 affected110 at risk
Blood pressure decreased	Investigations	MedDRA 18.0	Non-systematic Assessment		EG0006 affected111 at risk EG0014 affected110 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment		EG00010 affected111 at risk EG0015 affected110 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment		EG0007 affected111 at risk EG0017 affected110 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment		EG0008 affected111 at risk EG0016 affected110 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment		EG00011 affected111 at risk EG00114 affected110 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment		EG0002 affected111 at risk EG00111 affected110 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment		EG00011 affected111 at risk EG0019 affected110 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment		EG0006 affected111 at risk EG0013 affected110 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment		EG0008 affected111 at risk EG0015 affected110 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment		EG0005 affected111 at risk EG0017 affected110 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	As the event is gender specific, only female participants were evaluated.	EG0000 affected26 at risk EG0011 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0008 affected111 at risk EG0019 affected110 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0000 affected111 at risk EG0016 affected110 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0001 affected111 at risk EG0018 affected110 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment		EG0004 affected111 at risk EG0016 affected110 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment		EG0009 affected111 at risk EG0013 affected110 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment		EG0004 affected111 at risk EG0016 affected110 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
BG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
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	Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.			52	111	89	111
EG001	Placebo	Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.			65	110	87	110