Trial Outcomes & Findings for Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure (NCT NCT01115855)

NCT ID: NCT01115855

Last Updated: 2020-12-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 221 participants
• Primary outcome timeframe: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
• Results posted on: 2020-12-22

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	111	110
Overall Study COMPLETED	75	74
Overall Study NOT COMPLETED	36	36

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	16	18
Overall Study Death	6	5
Overall Study Lab Abnormality	1	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	5	5
Overall Study Other	8	6

Baseline Characteristics

Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

Baseline characteristics by cohort

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.	Total n=221 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.7 • n=5 Participants	68.4 years STANDARD_DEVIATION 7.7 • n=7 Participants	68.7 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male FEMALE	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male MALE	85 Participants n=5 Participants	91 Participants n=7 Participants	176 Participants n=5 Participants

PRIMARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)	33 participants	36 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication	42 participants	45 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With With First Occurrence of All-Cause Mortality During treatment	6 participants	5 participants
Number of Participants With With First Occurrence of All-Cause Mortality Within 30 days of treatment discontinuation	1 participants	1 participants
Number of Participants With With First Occurrence of All-Cause Mortality After 30 days of treatment discontinuation	10 participants	4 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With With First Occurrence of Cardiovascular Mortality	14 participants	6 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of All-cause Hospitalization	45 participants	58 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)	27 participants	33 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization	48 participants	61 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization	29 participants	33 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization	35 participants	44 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening	38 participants	43 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke	3 participants	4 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)	1 participants	1 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter	4 participants	2 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of New Onset Diabetes Mellitus	1 participants	2 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function	2 participants	2 participants

SECONDARY outcome

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

Population: Full analysis set included all randomized participants.

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
Number of Participants With First Occurrence of Hospitalization for Hyperkalemia	0 participants	0 participants

SECONDARY outcome

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

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Baseline (n=111,110)	469.29 picogram/milliliter (pg/ml) Standard Deviation 375.43	435.61 picogram/milliliter (pg/ml) Standard Deviation 391.49
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 Change at Month 5 (n=105,106)	-169.75 picogram/milliliter (pg/ml) Standard Deviation 424.40	-36.36 picogram/milliliter (pg/ml) Standard Deviation 413.73
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 Change at Month 9 (n=99,104)	-208.54 picogram/milliliter (pg/ml) Standard Deviation 405.74	-76.23 picogram/milliliter (pg/ml) Standard Deviation 442.47
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 Change at Month 13 (n=95,101)	-258.66 picogram/milliliter (pg/ml) Standard Deviation 395.05	-93.99 picogram/milliliter (pg/ml) Standard Deviation 409.87
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 Change at Month 17 (n=81,82)	-242.92 picogram/milliliter (pg/ml) Standard Deviation 431.59	-69.74 picogram/milliliter (pg/ml) Standard Deviation 535.05
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 Change at Month 21 (n=72,73)	-241.33 picogram/milliliter (pg/ml) Standard Deviation 429.24	-57.31 picogram/milliliter (pg/ml) Standard Deviation 515.76
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 Change at Month 25 (n=63,63)	-249.76 picogram/milliliter (pg/ml) Standard Deviation 473.68	-83.99 picogram/milliliter (pg/ml) Standard Deviation 506.79
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 Change at Month 29 (n=53,48)	-269.07 picogram/milliliter (pg/ml) Standard Deviation 502.78	-95.33 picogram/milliliter (pg/ml) Standard Deviation 350.51
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 Change at Month 33 (n=45,40)	-228.84 picogram/milliliter (pg/ml) Standard Deviation 575.05	-43.98 picogram/milliliter (pg/ml) Standard Deviation 500.78
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 Change at Month 37 (n=40,33)	-211.86 picogram/milliliter (pg/ml) Standard Deviation 597.30	-73.73 picogram/milliliter (pg/ml) Standard Deviation 626.13
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 Change at Month 42 (n=30,26)	-155.65 picogram/milliliter (pg/ml) Standard Deviation 320.44	-22.31 picogram/milliliter (pg/ml) Standard Deviation 689.26
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 Change at Month 48 (n=16,16)	-200.85 picogram/milliliter (pg/ml) Standard Deviation 357.51	-122.33 picogram/milliliter (pg/ml) Standard Deviation 450.87
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 Change at Final Visit (n=109,110)	-149.75 picogram/milliliter (pg/ml) Standard Deviation 473.95	-57.45 picogram/milliliter (pg/ml) Standard Deviation 509.85

SECONDARY outcome

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

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Baseline (n=111,110)	2635.78 pg/mL Standard Deviation 2143.64	2354.31 pg/mL Standard Deviation 1874.30
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 Change at Month 5 (n=105,106)	-770.51 pg/mL Standard Deviation 2172.88	-205.18 pg/mL Standard Deviation 1801.42
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 Change at Month 9 (n=99,104)	-884.76 pg/mL Standard Deviation 2265.57	-425.47 pg/mL Standard Deviation 1883.54
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 Change at Month 13 (n=95,101)	-1066.86 pg/mL Standard Deviation 2088.51	-452.02 pg/mL Standard Deviation 1878.98
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 Change at Month 17 (n=81,82)	-1126.96 pg/mL Standard Deviation 2384.14	-109.59 pg/mL Standard Deviation 3380.42
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 Change at Month 21 (n=72,73)	-957.86 pg/mL Standard Deviation 2601.47	-250.85 pg/mL Standard Deviation 2508.01
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 Change at Month 25 (n=63,63)	-453.57 pg/mL Standard Deviation 4894.51	-128.02 pg/mL Standard Deviation 2627.01
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 Change at Month 29 (n=53,48)	-1013.83 pg/mL Standard Deviation 3167.91	-187.08 pg/mL Standard Deviation 2524.52
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 Change at Month 33 (n=45,40)	-168.36 pg/mL Standard Deviation 5404.82	434.35 pg/mL Standard Deviation 5134.98
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 Change at Month 37 (n=40,33)	-9.64 pg/mL Standard Deviation 5188.24	171.21 pg/mL Standard Deviation 5081.43
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 Change at Month 42 (n=30,26)	-246.77 pg/mL Standard Deviation 4753.87	928.35 pg/mL Standard Deviation 6494.32
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 Change at Month 48 (n=16,16)	-970.71 pg/mL Standard Deviation 4833.60	-450.69 pg/mL Standard Deviation 1487.78
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 Change at Final Visit (n=109,110)	-177.00 pg/mL Standard Deviation 3780.44	296.35 pg/mL Standard Deviation 3823.59

SECONDARY outcome

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

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

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Baseline (n=111,110)	25.64 percentage of LVEF Standard Deviation 4.95	26.64 percentage of LVEF Standard Deviation 3.97
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 Change at Month 5 (n=105,106)	5.98 percentage of LVEF Standard Deviation 8.87	4.01 percentage of LVEF Standard Deviation 7.59
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 Change at Month 9 (n=99,104)	33.89 percentage of LVEF Standard Deviation 10.64	31.37 percentage of LVEF Standard Deviation 9.19
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 Change at Month 13 (n=94,101)	9.62 percentage of LVEF Standard Deviation 9.70	4.86 percentage of LVEF Standard Deviation 10.13
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 Change at Month 17 (n=81,82)	11.36 percentage of LVEF Standard Deviation 11.45	5.50 percentage of LVEF Standard Deviation 10.74
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 Change at Month 21 (n=72,73)	12.73 percentage of LVEF Standard Deviation 12.04	6.37 percentage of LVEF Standard Deviation 11.88
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 Change at Month 25 (n=63,64)	12.18 percentage of LVEF Standard Deviation 12.18	6.60 percentage of LVEF Standard Deviation 10.94
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 Change at Month 29 (n=53,48)	11.95 percentage of LVEF Standard Deviation 12.28	6.45 percentage of LVEF Standard Deviation 12.83
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 Change at Month 33 (n=45,39)	13.67 percentage of LVEF Standard Deviation 13.94	5.20 percentage of LVEF Standard Deviation 10.19
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 Change at Month 37 (n=40,33)	13.34 percentage of LVEF Standard Deviation 14.59	7.18 percentage of LVEF Standard Deviation 10.49
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 Change at Month 42 (n=30,26)	12.15 percentage of LVEF Standard Deviation 14.38	5.13 percentage of LVEF Standard Deviation 10.36
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 Change at Month 48 (n=16,16)	10.18 percentage of LVEF Standard Deviation 16.02	8.41 percentage of LVEF Standard Deviation 11.51
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 Change at Final Visit (n=109,110)	9.50 percentage of LVEF Standard Deviation 12.03	5.99 percentage of LVEF Standard Deviation 11.04

SECONDARY outcome

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

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

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Baseline (n=111,108)	169.82 microgram per gram creatinine (mg/gCr) Standard Deviation 787.32	154.93 microgram per gram creatinine (mg/gCr) Standard Deviation 366.44
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 Change at Month 5 (n=104,103)	-21.14 microgram per gram creatinine (mg/gCr) Standard Deviation 359.53	46.23 microgram per gram creatinine (mg/gCr) Standard Deviation 377.56
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 Change at Month 9 (n=98,101)	-11.10 microgram per gram creatinine (mg/gCr) Standard Deviation 249.68	23.79 microgram per gram creatinine (mg/gCr) Standard Deviation 362.35
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 Change at Month 13 (n=94,98)	-41.56 microgram per gram creatinine (mg/gCr) Standard Deviation 322.12	-19.04 microgram per gram creatinine (mg/gCr) Standard Deviation 253.57
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 Change at Month 17 (n=80,82)	-13.66 microgram per gram creatinine (mg/gCr) Standard Deviation 247.48	79.28 microgram per gram creatinine (mg/gCr) Standard Deviation 530.74
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 Change at Month 21 (n=72,73)	-63.65 microgram per gram creatinine (mg/gCr) Standard Deviation 498.00	28.84 microgram per gram creatinine (mg/gCr) Standard Deviation 431.48
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 Change at Month 25 (n=62,63)	17.17 microgram per gram creatinine (mg/gCr) Standard Deviation 489.08	30.08 microgram per gram creatinine (mg/gCr) Standard Deviation 350.86
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 Change at Month 29 (n=50,47)	18.51 microgram per gram creatinine (mg/gCr) Standard Deviation 454.75	-4.58 microgram per gram creatinine (mg/gCr) Standard Deviation 504.53
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 Change at Month 33 (n=43,39)	-47.07 microgram per gram creatinine (mg/gCr) Standard Deviation 506.66	-3.38 microgram per gram creatinine (mg/gCr) Standard Deviation 417.43
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 Change at Month 37 (n=39,33)	-80.21 microgram per gram creatinine (mg/gCr) Standard Deviation 743.85	34.20 microgram per gram creatinine (mg/gCr) Standard Deviation 393.95
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 Change at Month 42 (n=27,25)	-162.18 microgram per gram creatinine (mg/gCr) Standard Deviation 921.61	-29.95 microgram per gram creatinine (mg/gCr) Standard Deviation 187.19
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 Change at Month 48 (n=16,16)	-303.19 microgram per gram creatinine (mg/gCr) Standard Deviation 1211.28	-41.03 microgram per gram creatinine (mg/gCr) Standard Deviation 113.70
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 Change at Final Visit (n=109,110)	-29.30 microgram per gram creatinine (mg/gCr) Standard Deviation 597.07	-31.56 microgram per gram creatinine (mg/gCr) Standard Deviation 271.71

SECONDARY outcome

Timeframe: 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)

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

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).

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Month 2 (n=109, 109) : Unchanged	94 participants	95 participants
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 Week 1 (n=111, 110) : Worse	0 participants	1 participants
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 Week 4 (n=111, 108) : Improved	10 participants	14 participants
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 Week 4 (n=111, 108) : Unchanged	101 participants	92 participants
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 Week 4 (n=111, 108) : Worse	0 participants	2 participants
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 Month 2 (n=109, 109) : Improved	15 participants	14 participants
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 Month 2 (n=109, 109) : Worse	0 participants	0 participants
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 Month 3 (n=106, 107) : Improved	18 participants	16 participants
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 Month 3 (n=106, 107) : Unchanged	88 participants	91 participants
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 Month 3 (n=106, 107) : Worse	0 participants	0 participants
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 Month 4 (n=106, 106) : Improved	22 participants	20 participants
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 Month 4 (n=106, 106) : Unchanged	82 participants	86 participants
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 Month 4 (n=106, 106) : Worse	2 participants	0 participants
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 Month 5 (n=104, 106) : Improved	24 participants	22 participants
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 Month 5 (n=104, 106) : Unchanged	76 participants	83 participants
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 Month 5 (n=104, 106) : Worse	4 participants	1 participants
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 Month 9 (n=99, 105) : Improved	27 participants	20 participants
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 Month 9 (n=99, 105) : Unchanged	71 participants	81 participants
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 Month 9 (n=99, 105) : Worse	1 participants	4 participants
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 Month 13 (n=94, 102) : Improved	31 participants	19 participants
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 Month 13 (n=94, 102) : Unchanged	62 participants	82 participants
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 Month 13 (n=94, 102) : Worse	1 participants	1 participants
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 Month 17 (n=81, 82) : Improved	25 participants	18 participants
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 Month 17 (n=81, 82) : Unchanged	55 participants	61 participants
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 Month 17 (n=81, 82) : Worse	1 participants	3 participants
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 Month 21 (n=72, 73) : Improved	21 participants	19 participants
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 Month 21 (n=72, 73) : Unchanged	50 participants	51 participants
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 Month 21 (n=72, 73) : Worse	1 participants	3 participants
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 Month 25 (n=63, 64) : Improved	23 participants	14 participants
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 Month 25 (n=63, 64) : Unchanged	38 participants	48 participants
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 Month 25 (n=63, 64) : Worse	2 participants	2 participants
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 Month 29 (n=53, 48) : Improved	17 participants	12 participants
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 Month 29 (n=53, 48) : Unchanged	36 participants	35 participants
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 Month 29 (n=53, 48) : Worse	0 participants	1 participants
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 Month 33 (n=46, 39) : Improved	14 participants	10 participants
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 Month 33 (n=46, 39) : Unchanged	31 participants	27 participants
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 Month 33 (n=46, 39) : Worse	1 participants	2 participants
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 Month 37 (n=40, 33) : Improved	12 participants	10 participants
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 Month 37 (n=40, 33) : Unchanged	28 participants	22 participants
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 Month 37 (n=40, 33) : Worse	0 participants	1 participants
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 Month 42 (n=30, 26) : Improved	7 participants	7 participants
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 Month 42 (n=30, 26) : Unchanged	23 participants	18 participants
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 Month 42 (n=30, 26) : Worse	0 participants	1 participants
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 Month 48 (n=16, 16) : Improved	2 participants	6 participants
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 Month 48 (n=16, 16) : Unchanged	14 participants	9 participants
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 Month 48 (n=16, 16) : Worse	0 participants	1 participants
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 Final Visit (n=111, 110) : Improved	25 participants	26 participants
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 Final Visit (n=111, 110) : Unchanged	80 participants	80 participants
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 Final Visit (n=111, 110) : Worse	6 participants	4 participants
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 Week 1 (n=111, 110) : Improved	4 participants	2 participants
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 Week 1 (n=111, 110) : Unchanged	107 participants	107 participants

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Eplerenone n=111 Participants 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.	Placebo n=110 Participants 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.
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 Change at Month 25 (n=63,63)	0.48 metabolic equivalents (METs) Standard Deviation 1.08	0.63 metabolic equivalents (METs) Standard Deviation 1.72
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 Baseline (n=111,110)	4.85 metabolic equivalents (METs) Standard Deviation 1.51	4.89 metabolic equivalents (METs) Standard Deviation 1.54
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 Change at Week 4 (n= 111,108)	0.15 metabolic equivalents (METs) Standard Deviation 0.79	0.27 metabolic equivalents (METs) Standard Deviation 1.08
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 Change at Month 5 (n=104,106)	0.46 metabolic equivalents (METs) Standard Deviation 1.15	0.33 metabolic equivalents (METs) Standard Deviation 1.19
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 Change at Month 9 (n=99,104)	0.41 metabolic equivalents (METs) Standard Deviation 1.16	0.37 metabolic equivalents (METs) Standard Deviation 1.39
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 Change at Month 13 (n=94,102)	0.52 metabolic equivalents (METs) Standard Deviation 1.18	0.44 metabolic equivalents (METs) Standard Deviation 1.45
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 Change at Month 17 (n=81,82)	0.46 metabolic equivalents (METs) Standard Deviation 1.38	0.47 metabolic equivalents (METs) Standard Deviation 1.81
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 Change at Month 21 (n=72,73)	0.34 metabolic equivalents (METs) Standard Deviation 1.33	0.59 metabolic equivalents (METs) Standard Deviation 1.64
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 Change at Month 29 (n=53,48)	0.42 metabolic equivalents (METs) Standard Deviation 1.14	0.65 metabolic equivalents (METs) Standard Deviation 1.56
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 Change at Month 33 (n=46,40)	0.37 metabolic equivalents (METs) Standard Deviation 1.28	0.51 metabolic equivalents (METs) Standard Deviation 1.80
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 Change at Month 37 (n=40,33)	0.53 metabolic equivalents (METs) Standard Deviation 1.47	0.68 metabolic equivalents (METs) Standard Deviation 1.39
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 Change at Month 42 (n=30,26)	0.39 metabolic equivalents (METs) Standard Deviation 1.70	0.47 metabolic equivalents (METs) Standard Deviation 1.83
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 Change at Month 48 (n=16,16)	-0.13 metabolic equivalents (METs) Standard Deviation 1.57	0.64 metabolic equivalents (METs) Standard Deviation 1.59
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 Change at Final Visit (n=111,110)	0.14 metabolic equivalents (METs) Standard Deviation 1.56	0.25 metabolic equivalents (METs) Standard Deviation 1.65

Adverse Events

Eplerenone

Serious events: 52 serious events

Other events: 89 other events

Deaths: 0 deaths

Placebo

Serious events: 65 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eplerenone n=111 participants at risk 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.	Placebo n=110 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Bone marrow failure	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Angina pectoris	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	3.6% 4/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Angina unstable	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Arrhythmia	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial fibrillation	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial flutter	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Bradycardia	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure	24.3% 27/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	28.2% 31/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure acute	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure chronic	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure congestive	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac sarcoidosis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardio-respiratory arrest	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Congestive cardiomyopathy	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Coronary artery stenosis	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Intracardiac thrombus	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Mitral valve incompetence	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Myocardial infarction	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Ventricular fibrillation	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Ventricular tachycardia	4.5% 5/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Cataract	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Retinal detachment	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric ulcer	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Inguinal hernia	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Large intestine polyp	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Pancreatitis acute	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Protein-losing gastroenteropathy	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Chest discomfort	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Chest pain	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Malaise	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Multi-organ failure	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Sudden cardiac death	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Sudden death	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholecystitis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Appendicitis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchitis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchopneumonia	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cellulitis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Device related infection	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Disseminated tuberculosis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Endocarditis bacterial	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Gastroenteritis	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Influenza	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Peritonitis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia	3.6% 4/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.5% 5/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia bacterial	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia staphylococcal	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyelonephritis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sepsis	2.7% 3/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Muscle injury	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Postoperative ileus	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Blood pressure decreased	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Dehydration	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Fluid retention	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma recurrent	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebellar infarction	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral haemorrhage	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral infarction	2.7% 3/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebrovascular accident	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cervical myelopathy	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Loss of consciousness	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Spondylitic myelopathy	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Subarachnoid haemorrhage	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Syncope	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Chronic kidney disease	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal failure	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal impairment	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Extremity necrosis	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Haemorrhage	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypotension	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.91% 1/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.8% 2/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Peripheral artery aneurysm	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Other adverse events

Measure	Eplerenone n=111 participants at risk 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.	Placebo n=110 participants at risk 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.
Blood and lymphatic system disorders Anaemia	6.3% 7/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure	18.9% 21/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	29.1% 32/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Chronic gastritis	5.4% 6/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Constipation	7.2% 8/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	16.4% 18/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diarrhoea	6.3% 7/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	9.1% 10/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haemorrhoids	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatic function abnormal	3.6% 4/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.4% 7/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchitis	5.4% 6/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.3% 8/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Conjunctivitis	6.3% 7/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.5% 5/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Nasopharyngitis	33.3% 37/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	36.4% 40/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Upper respiratory tract infection	4.5% 5/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Contusion	10.8% 12/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.5% 5/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	18.0% 20/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	18.2% 20/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Blood pressure decreased	5.4% 6/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	3.6% 4/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Dehydration	9.0% 10/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.5% 5/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	6.3% 7/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.4% 7/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	7.2% 8/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	9.9% 11/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	12.7% 14/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hypokalaemia	1.8% 2/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	10.0% 11/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	9.9% 11/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.2% 9/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 6/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Dizziness	7.2% 8/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.5% 5/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal impairment	4.5% 5/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.4% 7/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/26 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.3% 1/19 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	7.2% 8/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.2% 9/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.90% 1/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.3% 8/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Eczema	3.6% 4/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypertension	8.1% 9/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.7% 3/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypotension	3.6% 4/111 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.5% 6/110 The same event may appear as both an adverse event and an serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER