Phase IIb Safety and Efficacy Study of Different Oral Dos... | NCT01807221

NCT01807221

ID	Type	Description	Link
2012-002627-15	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Finerenone(BAY94-8862)[2.5mg] + Placebo	Experimental	Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: Finerenone (BAY94-8862) Drug: Placebo
Finerenone (BAY94-8862)[5mg] + Placebo	Experimental	Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: Finerenone (BAY94-8862) Drug: Placebo
Finerenone (BAY94-8862)[7.5mg] + Placebo	Experimental	Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: Finerenone (BAY94-8862) Drug: Placebo
Finerenone (BAY94-8862)[10mg] + Placebo	Experimental	Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: Finerenone (BAY94-8862) Drug: Placebo
Finerenone (BAY94-8862)[15mg] + Placebo	Experimental	Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finerenone (BAY94-8862)	Drug		Finerenone (BAY94-8862)[10mg] + Placebo Finerenone (BAY94-8862)[15mg] + Placebo Finerenone (BAY94-8862)[5mg] + Placebo Finerenone (BAY94-8862)[7.5mg] + Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90	N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.	Baseline and Day 90

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Death Due to Any Cause	Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.	Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Number of Participants With Cardiovascular Hospitalization

Other Outcomes

Measure	Description	Time Frame
Change From Baseline in Serum Potassium at Specified Visits		Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Systolic Blood Pressure at Specified Visits		Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294-2041	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27130705	Result	Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.
33107592

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Finerenone(BAY94-8862)[2.5mg] + Placebo

Safety analysis set (SAF): all randomized participants who took at least one dose of study drug and with data after beginning of treatment.

Arm/Group Information

ID	Title	Description
BG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
BG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
BG002	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
BG003	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
BG004	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
BG005	Finerenone (BAY94-8862) 15-20 mg OD	Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000221 ParticipantsBG001172 ParticipantsBG002163 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000221 ParticipantsBG001172 ParticipantsBG002

Baseline BNP

B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Participants with valid data for this baseline characteristic

Geometric Mean

Standard Deviation

pg/ml

Title	Denominators	Categories
	ParticipantsBG000203 ParticipantsBG001156 ParticipantsBG002

Baseline NT-proBNP

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Participants with valid data for this baseline characteristic

Geometric Mean

Standard Deviation

pg/ml

Title	Denominators	Categories
	ParticipantsBG000207 ParticipantsBG001162 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Full analysis set (FAS): all participants who the study drug, had baseline and at least one post-baseline NT-proBNP value or who died or experienced permanent (≥5 consecutive days) withdrawal of study drug after cardiovascular (CV) hospitalization or after emergency presentation for Worsening Chronic Heart Failure (WCHF)

Posted

Number

90% Confidence Interval

Percentage of participants

Baseline and Day 90

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG003	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG004	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG005	Finerenone (BAY94-8862) 15-20 mg OD	Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

Units	Counts
Participants	OG000207 OG001162 OG002157 OG003

Title

Denominators

Categories

Title	Measurements
	OG00037.2± 31.6(31.6 to 43.1) OG00130.9± 24.9(24.9 to 37.4) OG00232.5± 26.3(26.3 to 39.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.	Chi-squared		0.8771		Mean Difference (Final Values)	-6.3			2-Sided	90	-14.9	2.3					Other

Secondary

Number of Participants With Death Due to Any Cause

Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.

Participants in FAS

Posted

Count of Participants

Participants

Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD

Secondary

Number of Participants With Cardiovascular Hospitalization

Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.

Participants in FAS

Posted

Count of Participants

Participants

Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

Secondary

Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)

Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.

Participants in FAS

Posted

Count of Participants

Participants

Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002

Secondary

Ratio of BNP at Specified Visits to BNP at Baseline

B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Participants in FAS with valid data at specified visits

Posted

Geometric Mean

Standard Deviation

Ratio

Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

Secondary

Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline

Participants in FAS with valid data at specified visits

Posted

Geometric Mean

Standard Deviation

Ratio

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

Secondary

Change From Baseline in KCCQ Questionnaire Scores at Specified Visits

The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.

Participants in FAS with valid data at specified visits

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Day 30 and Day 90

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD

Secondary

Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits

EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.

Participants in FAS with valid data at specified visits

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001

Other Pre-specified

Change From Baseline in Serum Potassium at Specified Visits

Participants in SAF with valid data at specified visits

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

Other Pre-specified

Change From Baseline in Systolic Blood Pressure at Specified Visits

Participants in SAF with valid data at specified visits

Posted

Mean

Standard Deviation

millimeter of mercury (mmHg)

Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD

Other Pre-specified

Change From Baseline in Diastolic Blood Pressure at Specified Visits

Participants in SAF with valid data at specified visits

Posted

Mean

Standard Deviation

millimeter for mercury (mmHg)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD

Other Pre-specified

Change From Baseline in Heart Rate at Specified Visits

Participants in SAF with valid data at specified visits

Posted

Mean

Standard Deviation

Beats per minute (Beats/min)

ID	Title	Description
OG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.
OG001	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.
OG002	Finerenone (BAY94-8862) 5-10 mg OD

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eplerenone (INSPRA®)	Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days.	19	221	77	221	85	221
EG001	Finerenone(BAY94-8862) 2.5-5 mg OD	Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo-matched to Eplerenone capsule OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.	17	172	72	172	63	172
EG002	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.	9	163	47	163	59	163
EG003	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.	12	167	52	167	50	167
EG004	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.	2	169	46	169	50	169
EG005	Finerenone (BAY94-8862) 15-20 mg OD	Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.	9	163	57	163	65	163

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG0030 events0 affected167 at risk EG0040 events0 affected169 at risk EG0050 events0 affected163 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0003 events3 affected221 at risk EG0011 events1 affected172 at risk EG0021 events1 affected163 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG00027 events21 affected221 at risk EG00126 events16 affected172 at risk EG00217 events15 affected163 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0006 events6 affected221 at risk EG0016 events6 affected172 at risk EG0023 events3 affected163 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG00016 events13 affected221 at risk EG00111 events9 affected172 at risk EG0027 events7 affected163 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0005 events4 affected221 at risk EG0015 events5 affected172 at risk EG0022 events2 affected163 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0003 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pericardial haemorrhage	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0003 events3 affected221 at risk EG0014 events3 affected172 at risk EG0020 events0 affected163 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0018 events4 affected172 at risk EG0020 events0 affected163 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cataract	Eye disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cataract nuclear	Eye disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Chest pain	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Malaise	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Pyrexia	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Sudden death	General disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0012 events2 affected172 at risk EG0021 events1 affected163 at risk EG003
Sudden cardiac death	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0022 events2 affected163 at risk EG003
Oedema due to cardiac disease	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Implant site haematoma	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Implant site ulcer	General disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Stent-graft endoleak	General disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Bronchitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0021 events1 affected163 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0012 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cellulitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0022 events2 affected163 at risk EG003
Endocarditis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Erysipelas	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Lymphangitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Pneumonia	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0013 events3 affected172 at risk EG0023 events3 affected163 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Sepsis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Septic shock	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Rectal abscess	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Escherichia infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Enterocolitis bacterial	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Blood creatinine increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Blood potassium increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0022 events2 affected163 at risk EG003
International normalised ratio increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Computerised tomogram abdomen abnormal	Investigations	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Troponin T increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0005 events5 affected221 at risk EG0016 events6 affected172 at risk EG0024 events4 affected163 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cerebellar syndrome	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Dizziness	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Syncope	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cerebrovascular insufficiency	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Delirium	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events1 affected172 at risk EG0021 events1 affected163 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Nephropathy toxic	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0012 events2 affected172 at risk EG0021 events1 affected163 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0015 events5 affected172 at risk EG0021 events1 affected163 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0021 events1 affected163 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0003 events2 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardioversion	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Foot amputation	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0012 events2 affected172 at risk EG0020 events0 affected163 at risk EG003
Ventricular assist device insertion	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Cardiac rehabilitation therapy	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events2 affected172 at risk EG0020 events0 affected163 at risk EG003
Cardiac ablation	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Hypotension	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected172 at risk EG0020 events0 affected163 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0021 events1 affected163 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003
Haemodynamic instability	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0000 events0 affected221 at risk EG0010 events0 affected172 at risk EG0020 events0 affected163 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA (17.1)	Systematic Assessment	EG00014 events13 affected221 at risk EG00120 events14 affected172 at risk EG00211 events10 affected163 at risk EG0036 events5 affected167 at risk EG0047 events7 affected169 at risk EG00510 events10 affected163 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0008 events8 affected221 at risk EG0016 events6 affected172 at risk EG0026 events6 affected163 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0007 events7 affected221 at risk EG00112 events9 affected172 at risk EG0022 events2 affected163 at risk EG003
Blood creatinine increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG00014 events12 affected221 at risk EG0015 events5 affected172 at risk EG0027 events7 affected163 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0009 events8 affected221 at risk EG0015 events5 affected172 at risk EG00210 events7 affected163 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG00044 events34 affected221 at risk EG00126 events20 affected172 at risk EG00228 events21 affected163 at risk EG003
Dizziness	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG00013 events12 affected221 at risk EG0018 events8 affected172 at risk EG0027 events6 affected163 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (17.1)	Systematic Assessment	EG00010 events8 affected221 at risk EG0018 events6 affected172 at risk EG0029 events7 affected163 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Systematic Assessment	EG00012 events11 affected221 at risk EG00113 events12 affected172 at risk EG0027 events7 affected163 at risk EG003
Hypotension	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG00013 events11 affected221 at risk EG0017 events7 affected172 at risk EG00212 events11 affected163 at risk EG003

ID	Term
D006333	Heart Failure

ID	Term
C576501	finerenone
D000077545	Eplerenone

ParticipantsBG004169

ParticipantsBG005163

ParticipantsBG0061055

ParticipantsBG003167

ParticipantsBG004169

ParticipantsBG005163

ParticipantsBG0061055

ParticipantsBG003156

ParticipantsBG004158

ParticipantsBG005155

ParticipantsBG006979

ParticipantsBG003158

ParticipantsBG004160

ParticipantsBG005158

ParticipantsBG0061002

OG00337.3± 30.9(30.9 to 44.1)

OG00438.8± 32.3(32.3 to 45.5)

OG00534.2± 27.9(27.9 to 40.9)

Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days.

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0042 events2 affected169 at risk

EG0051 events1 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0052 events2 affected163 at risk

EG00412 events11 affected169 at risk

EG00514 events13 affected163 at risk

EG0044 events3 affected169 at risk

EG0055 events5 affected163 at risk

EG0046 events6 affected169 at risk

EG00516 events12 affected163 at risk

EG0040 events0 affected169 at risk

EG0057 events3 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0051 events1 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0051 events1 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0051 events1 affected163 at risk

EG0041 events1 affected169 at risk

EG0051 events1 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0052 events1 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0041 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0050 events0 affected163 at risk

EG0042 events1 affected169 at risk

EG0050 events0 affected163 at risk

EG0040 events0 affected169 at risk

EG0051 events1 affected163 at risk

EG0040 events0 affected169 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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