Trial Outcomes & Findings for Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (NCT NCT04435626)

NCT ID: NCT04435626

Last Updated: 2025-08-26

Results Overview

Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6016 participants
• Primary outcome timeframe: From randomization up until the end of study, with an average study duration of 32 months
• Results posted on: 2025-08-26

Participant Flow

Study was conducted at multiple centers in 37 countries/regions between 14-Sep-2020 (first participant first visit) and 14-Jun-2024 (last participant last visit).

Of the 7463 screened participants, 1447 were screening failures, 6016 were randomized. Of the 3011 participants randomized into the finerenone group and the 3005 into the placebo group, 8 and 7 participants respectively were prospectively excluded from analysis due to major Good Clinical Practice (GCP) violations.

Participant milestones

Measure	Finerenone (BAY94-8862) Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo Participants received matching placebo once daily.
Overall Study STARTED	3011	3005
Overall Study Valid for FAS	3003	2998
Overall Study COMPLETED	2996	2986
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Measure	Finerenone (BAY94-8862) Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo Participants received matching placebo once daily.
Overall Study Lost to Follow-up	1	5
Overall Study Withdrawal by Subject	6	7
Overall Study major GCP violations	8	7

Baseline Characteristics

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

Baseline characteristics by cohort

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.	Total n=6001 Participants Total of all reporting groups
Age, Continuous	71.94 Years STANDARD_DEVIATION 9.60 • n=5 Participants	72.04 Years STANDARD_DEVIATION 9.69 • n=7 Participants	71.99 Years STANDARD_DEVIATION 9.65 • n=5 Participants
Sex: Female, Male Female	1355 Participants n=5 Participants	1377 Participants n=7 Participants	2732 Participants n=5 Participants
Sex: Female, Male Male	1648 Participants n=5 Participants	1621 Participants n=7 Participants	3269 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants
Race (NIH/OMB) Asian	497 Participants n=5 Participants	499 Participants n=7 Participants	996 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	39 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) White	2366 Participants n=5 Participants	2369 Participants n=7 Participants	4735 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
NYHA class NYHA class II	2081 Participants n=5 Participants	2065 Participants n=7 Participants	4146 Participants n=5 Participants
NYHA class NYHA class III	903 Participants n=5 Participants	910 Participants n=7 Participants	1813 Participants n=5 Participants
NYHA class NYHA class IV	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
NYHA class missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Baseline LVEF	52.64 percentage of ejection fraction STANDARD_DEVIATION 7.82 • n=5 Participants	52.49 percentage of ejection fraction STANDARD_DEVIATION 7.81 • n=7 Participants	52.56 percentage of ejection fraction STANDARD_DEVIATION 7.81 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization up until the end of study, with an average study duration of 32 months

Population: Full analysis set

Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events	1083 events	1283 events

PRIMARY outcome

Timeframe: From randomization up until the end of study, with an average study duration of 32 months

Population: Full analysis set

Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events	624 Participants	719 Participants

SECONDARY outcome

Timeframe: From randomization up until the end of study, with an average study duration of 32 months

Population: Full analysis set

Number of total (first and recurrent) heart failure events.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Occurrence of Total (First and Recurrent) Heart Failure Events	842 events	1024 events

SECONDARY outcome

Timeframe: From randomization up until the end of study, with an average study duration of 32 months

Population: Full analysis set

Number of participants with total (first and recurrent) heart failure events.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Occurrence of Total (First and Recurrent) Heart Failure Events	479 Participants	573 Participants

SECONDARY outcome

Timeframe: From baseline to Month 6, 9 and 12

Population: Full analysis set with available KCCQ measurements

The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) is ranged from 0 to 100. A higher score (closer to 100) reflects fewer symptoms, indicating better heart failure symptom status.

For the change from baseline the combined and averaged result across the entire time frame is reported.

Outcome measures

Measure	Finerenone (BAY94-8862) n=2731 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2710 Participants Participants received matching placebo once daily.
Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)	7.99 score on scale Interval 7.37 to 8.62	6.43 score on scale Interval 5.79 to 7.07

SECONDARY outcome

Timeframe: from baseline to Month 12

Population: Full analysis set with available NYHA measurement at baseline

The New York Heart Association (NYHA) Functional Classification is a simple scale that classifies patients with heart failure based on the severity of their symptoms and how those symptoms affect their physical activity, which ranges from Class I to Class IV, a lower class number is indicative of a better condition. A patient was considered as having improved in NYHA class, if the NYHA class at Month 12 is at least one category improved compared to the baseline visit.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Proportion of Participants Who Showed Improvement in NHYA Class	0.179 Estimated proportion Interval 0.163 to 0.195	0.178 Estimated proportion Interval 0.162 to 0.194

SECONDARY outcome

Timeframe: From randomization up to end of study visit, with an average study duration of 32 months

Population: Full analysis set

Number of participants with renal composite events encompassing the components sustained decrease in eGFR ≥50% relative to baseline over at least 4 weeks, sustained eGFR decline to <15 mL/min/1.73 m2 over at least 4 weeks, initiation of chronic dialysis and renal transplantation.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
First Occurrence of Renal Composite Events	75 Participants	55 Participants

SECONDARY outcome

Timeframe: From randomization until end of study, with an average of 32 months

Population: Full analysis set (FAS)

Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.

Outcome measures

Measure	Finerenone (BAY94-8862) n=3003 Participants Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2998 Participants Participants received matching placebo once daily.
Occurence of All-cause Mortality (Full Analysis Set)	491 Participants	522 Participants

Adverse Events

Finerenone (BAY94-8862)

Serious events: 1157 serious events

Other events: 1317 other events

Deaths: 494 deaths

Placebo

Serious events: 1213 serious events

Other events: 1228 other events

Deaths: 528 deaths

Never Received Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Finerenone (BAY94-8862) n=2993 participants at risk Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2993 participants at risk Participants randomized to this group received matching placebo once daily.	Never Received Treatment n=15 participants at risk Participants were randomized to either Finerenone or Placebo but never received study intervention.
Blood and lymphatic system disorders Anaemia	1.1% 34/2993 • Number of events 42 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	1.0% 31/2993 • Number of events 36 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Anaemia macrocytic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Anaemia of chronic disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypotension	0.40% 12/2993 • Number of events 14 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Hypochromic anaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Iron deficiency anaemia	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypovolaemic shock	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Microcytic anaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Neutropenia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Normocytic anaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Splenic haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Nephrogenic anaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Blood loss anaemia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Acute myocardial infarction	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Angina pectoris	0.57% 17/2993 • Number of events 23 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.87% 26/2993 • Number of events 30 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Angina unstable	1.3% 38/2993 • Number of events 43 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	1.2% 36/2993 • Number of events 38 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Aortic valve incompetence	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Aortic valve stenosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Arrhythmia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Arrhythmia supraventricular	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Arteriosclerosis coronary artery	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrial fibrillation	2.6% 77/2993 • Number of events 95 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	2.4% 73/2993 • Number of events 101 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrial flutter	0.47% 14/2993 • Number of events 14 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrial tachycardia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrioventricular block	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrioventricular block complete	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrioventricular block second degree	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Bradycardia	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac amyloidosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac aneurysm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac arrest	0.40% 12/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac failure	0.60% 18/2993 • Number of events 18 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.60% 18/2993 • Number of events 20 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac failure acute	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac failure congestive	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac tamponade	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardio-respiratory arrest	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiogenic shock	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiovascular disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Conduction disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cor pulmonale	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Coronary artery disease	0.67% 20/2993 • Number of events 23 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.57% 17/2993 • Number of events 17 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Coronary artery occlusion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Coronary artery stenosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Left ventricular failure	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Mitral valve incompetence	0.20% 6/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Myocardial fibrosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Myocardial infarction	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Myocardial ischaemia	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Palpitations	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Pericardial effusion	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Pericarditis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Pericarditis constrictive	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Sinoatrial block	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Sinus bradycardia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Supraventricular extrasystoles	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Supraventricular tachycardia	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Tachycardia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Tachycardia paroxysmal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Tricuspid valve incompetence	0.03% 1/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Ventricular arrhythmia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Ventricular extrasystoles	0.13% 4/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Ventricular fibrillation	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Ventricular tachycardia	0.27% 8/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.43% 13/2993 • Number of events 18 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Atrial thrombosis	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac pseudoaneurysm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Bradyarrhythmia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiovascular deconditioning	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiopulmonary failure	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Acute coronary syndrome	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Diastolic dysfunction	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Dilated cardiomyopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Tricuspid valve disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac valve disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Mitral valve disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Stress cardiomyopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiorenal syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Microvascular coronary artery disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Sinus node dysfunction	0.40% 12/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Chronic coronary syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Congenital, familial and genetic disorders Dermoid cyst	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Congenital, familial and genetic disorders Familial amyloidosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Congenital, familial and genetic disorders Janus kinase 2 mutation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Ear and labyrinth disorders Tinnitus	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Ear and labyrinth disorders Vertigo	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Ear and labyrinth disorders Vertigo positional	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Ear and labyrinth disorders Hypoacusis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Endocrine disorders Cushing's syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Endocrine disorders Hyperthyroidism	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Cataract	0.27% 8/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Cataract subcapsular	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Diabetic eye disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Diplopia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Dry eye	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Glaucoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Macular degeneration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Open angle glaucoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Ophthalmoplegia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Retinal detachment	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Vitreous haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Age-related macular degeneration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Eye disorders Neovascular age-related macular degeneration	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal adhesions	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal discomfort	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal pain	0.20% 6/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Acute abdomen	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Anal fistula	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Ascites	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Chronic gastritis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Colitis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Colitis ischaemic	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Constipation	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Dental caries	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Diarrhoea	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Diverticulum	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Duodenal ulcer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Duodenitis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Dysphagia	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Enteritis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Enterocolitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastric polyps	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastric ulcer	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastric ulcer perforation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastritis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastritis erosive	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.57% 17/2993 • Number of events 17 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrointestinal necrosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Haematemesis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Haematochezia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Haemorrhoids	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Hiatus hernia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Ileus	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Ileus paralytic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Incarcerated inguinal hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Inguinal hernia	0.23% 7/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.47% 14/2993 • Number of events 15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Inguinal hernia, obstructive	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Intestinal ischaemia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Intestinal obstruction	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Intestinal perforation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Irritable bowel syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Large intestine perforation	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Melaena	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Nausea	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Obstruction gastric	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Obturator hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oedema mouth	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oesophageal achalasia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Oesophagitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Pancreatic haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Pancreatitis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Pancreatitis acute	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Rectal haemorrhage	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Rectal ulcer haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Small intestinal perforation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Tooth impacted	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Umbilical hernia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Vomiting	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Pancreatic mass	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.27% 8/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Large intestine polyp	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Acquired oesophageal web	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Salivary gland mass	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Hernial eventration	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Intestinal haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Duodenogastric reflux	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Erosive duodenitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrooesophageal sphincter insufficiency	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Gastrointestinal inflammation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Incarcerated umbilical hernia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Bile acid malabsorption	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Large intestinal stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Abdominal incarcerated hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Anal incontinence	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Obstructive pancreatitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Asthenia	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Chest discomfort	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Chest pain	0.77% 23/2993 • Number of events 31 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.74% 22/2993 • Number of events 23 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Condition aggravated	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Death	0.97% 29/2993 • Number of events 29 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	1.7% 52/2993 • Number of events 52 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Fatigue	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Gait disturbance	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Hyperpyrexia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Hypothermia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Impaired healing	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Incarcerated hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Malaise	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Oedema peripheral	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Pyrexia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Sudden death	0.53% 16/2993 • Number of events 16 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.57% 17/2993 • Number of events 17 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Sudden cardiac death	0.47% 14/2993 • Number of events 14 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.53% 16/2993 • Number of events 16 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders General physical health deterioration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Pacemaker generated arrhythmia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Inflammation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Polyp	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Non-cardiac chest pain	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Prosthetic cardiac valve thrombosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Accidental death	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Medical device site haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Vascular stent stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
General disorders Multiple organ dysfunction syndrome	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Acute hepatic failure	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Bile duct stone	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Biliary colic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholangitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholangitis acute	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholecystitis	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholecystitis acute	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholecystitis chronic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cholelithiasis	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hepatic cirrhosis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hepatic failure	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hepatitis alcoholic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Biliary dyskinesia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Hepatic lesion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Hepatobiliary disorders Congestive hepatopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Immune system disorders Amyloidosis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Immune system disorders Anaphylactic shock	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Immune system disorders Anaphylactoid reaction	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Immune system disorders Primary amyloidosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Immune system disorders Sarcoidosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Abdominal wall abscess	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Acute sinusitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Appendicitis	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Bacteraemia	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Bronchitis	0.43% 13/2993 • Number of events 14 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Bronchopulmonary aspergillosis allergic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Cellulitis	0.57% 17/2993 • Number of events 18 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.80% 24/2993 • Number of events 25 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Dacryocystitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Diverticulitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Encephalomyelitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Endocarditis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Endocarditis staphylococcal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Epididymitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Erysipelas	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Escherichia sepsis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Fournier's gangrene	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gangrene	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gas gangrene	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gastroenteritis	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gastroenteritis salmonella	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gastroenteritis viral	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Herpes zoster	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infected skin ulcer	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Influenza	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Liver abscess	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Localised infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Lower respiratory tract infection	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Nasopharyngitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Osteomyelitis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Osteomyelitis acute	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Osteomyelitis chronic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pelvic inflammatory disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Periodontitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Peritonitis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Peritonsillar abscess	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia	2.9% 87/2993 • Number of events 98 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	3.7% 110/2993 • Number of events 116 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia aspiration	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia influenzal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia legionella	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia moraxella	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia pseudomonal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia respiratory syncytial viral	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia viral	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Postoperative wound infection	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Prostatic abscess	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pulmonary tuberculosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pyelonephritis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pyelonephritis acute	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pyoderma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pyonephrosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Salmonellosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Sepsis	0.84% 25/2993 • Number of events 25 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.53% 16/2993 • Number of events 16 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Septic arthritis staphylococcal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Septic shock	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Skin infection	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Subacute endocarditis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Subcutaneous abscess	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Tooth abscess	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Tracheobronchitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Tuberculosis of intrathoracic lymph nodes	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Tuberculous pleurisy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Upper respiratory tract infection	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Urinary tract infection	0.97% 29/2993 • Number of events 31 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.87% 26/2993 • Number of events 28 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Urinary tract infection enterococcal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Wound infection	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Urosepsis	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Bursitis infective staphylococcal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Anal abscess	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Streptococcal sepsis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Neutropenic sepsis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Abscess limb	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Staphylococcal bacteraemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pulmonary sepsis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Coronavirus infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Escherichia urinary tract infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Candida pneumonia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Arthritis bacterial	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Urinary tract infection bacterial	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Citrobacter sepsis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Clostridium difficile infection	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Helicobacter infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Emphysematous cystitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Staphylococcal sepsis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Psoas abscess	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infective tenosynovitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Biliary sepsis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Abdominal sepsis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Staphylococcal infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Intervertebral discitis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Diabetic foot infection	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Abdominal abscess	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Bacterial infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pneumonia bacterial	0.23% 7/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Clostridial infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Escherichia infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gastroenteritis bacterial	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Respiratory syncytial virus infection	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Biliary tract infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Parainfluenzae virus infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Respiratory tract infection viral	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Respiratory tract infection	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Cholecystitis infective	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infective spondylitis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Acarodermatitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Enterocolitis bacterial	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Tongue abscess	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Post procedural infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Rotavirus infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Gastrointestinal viral infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infectious pleural effusion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Streptococcal endocarditis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Candida infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Meningoencephalitis viral	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Medical device site infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Medical device site joint infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Systemic infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Pulmonary paracoccidioidomycosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Vascular device infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations H3N2 influenza	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Large intestine infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Infected gouty tophus	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations COVID-19	2.3% 69/2993 • Number of events 69 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	2.4% 71/2993 • Number of events 73 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations COVID-19 pneumonia	0.94% 28/2993 • Number of events 28 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	1.0% 30/2993 • Number of events 30 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Suspected COVID-19	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations SARS-CoV-2 sepsis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Norovirus infection	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Klebsiella urinary tract infection	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Accident	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Ankle fracture	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Burns second degree	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Clavicle fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Compression fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Concussion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Extradural haematoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Fall	0.50% 15/2993 • Number of events 15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.47% 14/2993 • Number of events 14 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Femoral neck fracture	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Femur fracture	0.50% 15/2993 • Number of events 15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.57% 17/2993 • Number of events 17 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Foot fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Forearm fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Head injury	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Heat stroke	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Hip fracture	0.40% 12/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Humerus fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Hyphaema	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Incisional hernia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Jaw fracture	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Overdose	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Pulmonary contusion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Radius fracture	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Rib fracture	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Road traffic accident	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Snake bite	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Spinal compression fracture	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Spinal fracture	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Subdural haematoma	0.27% 8/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Synovial rupture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Tibia fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Shoulder fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Face injury	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Contusion	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Thermal burn	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Skin laceration	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Shunt stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Pelvic fracture	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Limb injury	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Lower limb fracture	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Post procedural haematoma	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Shunt aneurysm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Skin abrasion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Spinal column injury	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Toxicity to various agents	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Craniocerebral injury	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Meniscus injury	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Traumatic haemothorax	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Adjacent segment degeneration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Craniofacial fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Injury, poisoning and procedural complications Injury of conjunctiva	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Biopsy prostate	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Blood creatine phosphokinase MB increased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Blood potassium increased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Blood sodium decreased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Carcinoembryonic antigen increased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Glomerular filtration rate decreased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Haemoglobin decreased	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Heart rate decreased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Intraocular pressure decreased	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Ureteroscopy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Weight decreased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Weight increased	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations White blood cell count increased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Ejection fraction decreased	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Anticoagulation drug level above therapeutic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Renal function test abnormal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Occult blood positive	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Angiocardiogram	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations SARS-CoV-2 test positive	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Computerised tomogram heart abnormal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Alkalosis hypochloraemic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Cachexia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Dehydration	0.47% 14/2993 • Number of events 16 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Diabetes mellitus	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Failure to thrive	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Gout	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hyperglycaemia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hyperkalaemia	0.63% 19/2993 • Number of events 19 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypernatraemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypocalcaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypoglycaemia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypokalaemia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hyponatraemia	0.33% 10/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypovolaemia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Iron deficiency	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Lactic acidosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Marasmus	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Metabolic acidosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Mineral metabolism disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Adult failure to thrive	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Back pain	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Muscular weakness	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Myalgia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Pathological fracture	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Connective tissue inflammation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Foot deformity	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Spinal pain	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Musculoskeletal and connective tissue disorders Immobilisation syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of penis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary serous endometrial carcinoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Intermittent claudication	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma uterus	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to salivary gland	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Lymphoedema	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retroperitoneal neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.37% 11/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mediastinal neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung infiltration malignant	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rosai-Dorfman syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer metastatic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa cell tumour	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary-mucinous carcinoma of pancreas	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Orthostatic hypotension	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma stage II	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant gastric ulcer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Aphasia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Ataxia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Bell's palsy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Carotid artery stenosis	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cerebral artery occlusion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cerebral haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cerebral infarction	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cerebral ischaemia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cervicobrachial syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Dementia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Diabetic neuropathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Dizziness	0.40% 12/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Drop attacks	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Dysarthria	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Encephalopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Epilepsy	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Headache	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Hepatic encephalopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Hydrocephalus	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Intraventricular haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Loss of consciousness	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Movement disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Myelopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Neuralgia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Paraesthesia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Paralysis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Parkinsonism	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Polyneuropathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Post herpetic neuralgia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Presyncope	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Quadriplegia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Radiculopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Sciatica	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Seizure	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Spondylitic myelopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Subarachnoid haemorrhage	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Syncope	0.84% 25/2993 • Number of events 26 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.74% 22/2993 • Number of events 23 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Toxic encephalopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Transient ischaemic attack	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Wernicke's encephalopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Carotid artery occlusion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Quadriparesis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Spinal epidural haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Lumbar radiculopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Lacunar infarction	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Ischaemic stroke	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Parkinson's disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Metabolic encephalopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Vascular encephalopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Orthostatic intolerance	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Brain injury	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Post cardiac arrest syndrome	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Thoracic radiculopathy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Alcoholic encephalopathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Agitation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Completed suicide	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Confusional state	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Conversion disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Delirium	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Depression	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Disorientation	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Eating disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Hallucination	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Mania	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Panic attack	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Sleep disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Mental status changes	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Suicidal behaviour	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Somatic symptom disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Anuria	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Calculus bladder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Haematuria	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Hydronephrosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Intercapillary glomerulosclerosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Nephrolithiasis	0.07% 2/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Nephropathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Polyuria	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal artery stenosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal failure	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal infarct	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Ureteric stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Urinary incontinence	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Urinary retention	0.20% 6/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Urinary tract disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Postrenal failure	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal injury	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Diabetic nephropathy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal impairment	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Cystitis noninfective	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Chronic kidney disease	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Urethral stenosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Acute kidney injury	1.8% 54/2993 • Number of events 56 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.94% 28/2993 • Number of events 30 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Prerenal failure	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Ureterolithiasis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Subcapsular renal haematoma	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Breast mass	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Cystocele	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Uterine polyp	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Reproductive system and breast disorders Ovarian haemorrhage	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.33% 10/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.57% 17/2993 • Number of events 18 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.60% 18/2993 • Number of events 20 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.90% 27/2993 • Number of events 32 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Cough	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.47% 14/2993 • Number of events 17 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.43% 13/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.33% 10/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Malignant pleural effusion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.17% 5/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 12/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 6 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.37% 11/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.30% 9/2993 • Number of events 10 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Bronchial wall thickening	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Rash	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Skin ulcer	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.20% 6/2993 • Number of events 9 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Social circumstances Immobile	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Angioplasty	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Aortic valve replacement	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Appendicectomy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Bladder calculus removal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac pacemaker insertion	0.27% 8/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac pacemaker removal	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardioversion	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Carotid endarterectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cholecystectomy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cryotherapy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Glossectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Hip arthroplasty	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Inguinal hernia repair	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Knee arthroplasty	0.10% 3/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Leg amputation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Pelvic floor repair	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Renal stone removal	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Spinal laminectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Toe amputation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Transurethral prostatectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Umbilical hernia repair	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Ureteric calculus removal	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Urethrotomy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac pacemaker replacement	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Implantable defibrillator insertion	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Knee operation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Shoulder arthroplasty	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Coronary angioplasty	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Hip surgery	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cholelithotomy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Polypectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Rehabilitation therapy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Renal artery angioplasty	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Peripheral artery angioplasty	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Peripheral nerve decompression	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac resynchronisation therapy	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac ablation	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Haematoma evacuation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Cardiac operation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Colectomy	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Prostatectomy	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Gastrectomy	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Retinal operation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Shoulder operation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Percutaneous coronary intervention	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Intraocular lens implant	0.03% 1/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Eventration repair	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Urinary incontinence surgery	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Transcatheter aortic valve implantation	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Metabolic surgery	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Atrial appendage closure	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Surgical and medical procedures Drug titration	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Accelerated hypertension	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Aortic aneurysm	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Aortic dissection	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Aortic stenosis	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Arterial thrombosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Blood pressure fluctuation	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Circulatory collapse	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Embolism arterial	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Essential hypertension	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Femoral artery aneurysm	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Haematoma	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypertension	0.23% 7/2993 • Number of events 8 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.37% 11/2993 • Number of events 11 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypertensive crisis	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.23% 7/2993 • Number of events 7 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral ischaemia	0.17% 5/2993 • Number of events 5 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral vascular disorder	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Thrombosis	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Varicose ulceration	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Varicose vein	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Labile hypertension	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Shock haemorrhagic	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Dry gangrene	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Deep vein thrombosis	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral artery occlusion	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 2 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypertensive emergency	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.13% 4/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypertensive urgency	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Extremity necrosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.07% 2/2993 • Number of events 4 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Arterial haemorrhage	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Embolism	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral embolism	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Diabetic vascular disorder	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral arterial occlusive disease	0.33% 10/2993 • Number of events 13 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.27% 8/2993 • Number of events 12 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Aortic arteriosclerosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Aortic dissection rupture	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Subgaleal haematoma	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral artery stenosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral artery thrombosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Obstructive shock	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Peripheral venous disease	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Brachiocephalic arteriosclerosis	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Brachiocephalic artery stenosis	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Product Issues Device malfunction	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Product Issues Device dislocation	0.10% 3/2993 • Number of events 3 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Product Issues Device fastener issue	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Product Issues Device inappropriate shock delivery	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Product Issues Device loosening	0.00% 0/2993 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.03% 1/2993 • Number of events 1 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.

Other adverse events

Measure	Finerenone (BAY94-8862) n=2993 participants at risk Participants received finerenone 10 mg, 20 mg or 40 mg once daily.	Placebo n=2993 participants at risk Participants randomized to this group received matching placebo once daily.	Never Received Treatment n=15 participants at risk Participants were randomized to either Finerenone or Placebo but never received study intervention.
Blood and lymphatic system disorders Anaemia	5.6% 169/2993 • Number of events 193 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	5.4% 162/2993 • Number of events 178 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Cardiac disorders Cardiac failure	3.9% 116/2993 • Number of events 143 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	5.6% 168/2993 • Number of events 218 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Gastrointestinal disorders Diarrhoea	5.6% 167/2993 • Number of events 208 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	4.3% 129/2993 • Number of events 157 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations Urinary tract infection	5.0% 150/2993 • Number of events 184 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	5.0% 149/2993 • Number of events 194 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Infections and infestations COVID-19	9.8% 292/2993 • Number of events 301 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	9.9% 297/2993 • Number of events 318 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Investigations Glomerular filtration rate decreased	5.2% 156/2993 • Number of events 219 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	3.6% 107/2993 • Number of events 144 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hyperkalaemia	8.4% 252/2993 • Number of events 348 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	3.6% 107/2993 • Number of events 139 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Metabolism and nutrition disorders Hypokalaemia	2.9% 88/2993 • Number of events 105 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	6.5% 196/2993 • Number of events 255 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Nervous system disorders Dizziness	5.7% 170/2993 • Number of events 198 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	4.6% 137/2993 • Number of events 158 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Renal and urinary disorders Renal impairment	6.4% 193/2993 • Number of events 232 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	3.7% 110/2993 • Number of events 127 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypertension	3.4% 103/2993 • Number of events 121 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	6.0% 179/2993 • Number of events 215 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.
Vascular disorders Hypotension	7.0% 210/2993 • Number of events 240 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	4.3% 128/2993 • Number of events 143 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.	0.00% 0/15 • Treatment emergent adverse events (TEAEs) are considered from the start of study intervention up to 3 days after the last study intervention administration, with an average treatment duration of 28 months. In contrast, numbers for all-cause mortality listed below consider all deaths after randomization over the entire average study duration of 32 months, independent of treatment and including deaths which occurred after the end of study visit in the 4-week follow-up period. The safety analysis set (SAF) included FAS participants who took ≥1 dose of study drug. 10 finerenone (n=3003) and 5 placebo participants (n=2998) took no drug, leaving 2993 in each SAF group. Heart failure and renal events were not counted as adverse events. All-cause mortality for FAS includes deaths from randomization to study end.

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60