Patiromer for the Management of Hyperkalemia in Subjects... | NCT03888066

ID	Type	Description	Link
2018-005030-38	EudraCT Number

Name	Class
Syneos Health	OTHER

Patiromer for the Management of Hyperkalemia in Subjects... | NCT03888066 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Patiromer	Experimental	Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.	Drug: Patiromer
Group 2: Placebo	Placebo Comparator	Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patiromer	Drug	The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Serum K+ Levels From Baseline	Adjusted mean changes in serum K+ from Baseline.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

Secondary Outcomes

Measure	Description	Time Frame
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Cumulative incidence of the first event of hyperkalemia with a serum K+ value >5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time. Aalen-Johansen estimators of the cumulative incidence function with death as a competing event. CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter

Contacts/Locations Module

Name	Affiliation	Role
Peter Szecsödy, MD	Vifor Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigator Site 11-080		Alexander City	Alabama	35010	United States
Investigator Site 11-041

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41957746	Derived	Bayes-Genis A, Butler J, Stawowczyk E, Turner M, Lewis RD, Lloyd IT, Ramirez de Arellano A. Hyperkalemia management in heart failure and chronic kidney disease: a Spanish cost-effectiveness analysis of patiromer informed by the integrated DIAMOND trial and real-world evidence. BMC Health Serv Res. 2026 Apr 10;26(1):715. doi: 10.1186/s12913-026-14468-4.
39340493

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose). mEq/l = Milliequivalents Per Liter

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 23, 2021	Aug 25, 2022

Type	Comment	Reasons
Randomization Criterion #1		FG00024 subjects FG0010 subjects
Randomization Criteria #1, #2		FG0005 subjects FG0010 subjects
Randomization Criteria #1, #2 #4; AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criteria #1, #3		FG0001 subjects FG0010 subjects
Randomization Criteria #1, #4		FG0001 subjects FG0010 subjects
Randomization Crit #1, #4; Withdraw By Subject; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criteria #1, #4; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criterion #1; AE		FG0004 subjects FG0010 subjects
Randomization Criterion #1; AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criterion #1; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0002 subjects FG0010 subjects
Randomization Criterion #2		FG0005 subjects FG0010 subjects
Randomization Criteria #2, #3		FG0001 subjects FG0010 subjects
Randomization Criteria #2, #3, #4		FG0001 subjects FG0010 subjects
Randomization Criteria #2, #4		FG0004 subjects FG0010 subjects
Randomization Criterion #3		FG00011 subjects FG0010 subjects
Randomization Criteria #3, #4		FG0001 subjects FG0010 subjects
Randomization Criteria #3, #4; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L		FG0002 subjects FG0010 subjects
Randomization Criterion #3; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criterion #4		FG0003 subjects FG0010 subjects
Randomization Criterion #3; Physician Decision		FG0001 subjects FG0010 subjects
Randomization Criterion #4; AE		FG0004 subjects FG0010 subjects
Randomization Criterion #4; AE; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L		FG0001 subjects FG0010 subjects
Randomization Criterion #3; Exceeded 12 Weeks Of Run In		FG0001 subjects FG0010 subjects
Randomization Criterion #4; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0002 subjects FG0010 subjects
Randomization Criterion #4; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L		FG0001 subjects FG0010 subjects
AE (Adverse Event)		FG00017 subjects FG0010 subjects
AE; Withdrawal By Subject		FG0003 subjects FG0010 subjects
AE; Withdrawal By Subject; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG0001 subjects FG0010 subjects
AE; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L		FG0002 subjects FG0010 subjects
Withdrawal by Subject		FG00043 subjects FG0010 subjects
AE; Physician Decision		FG0001 subjects FG0010 subjects
1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L		FG00010 subjects FG0010 subjects
Withdrawal By Subject; Withdrawal Of Consent		FG0001 subjects FG0010 subjects
2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L		FG0006 subjects FG0010 subjects
Death		FG0001 subjects FG0010 subjects
Non-Compliance With Study Drug		FG0002 subjects FG0010 subjects
Physician Decision		FG0001 subjects FG0010 subjects
Protocol Violation		FG00013 subjects FG0010 subjects
Sponsor Request		FG00034 subjects FG0010 subjects
Study Terminated By Sponsor		FG00071 subjects FG0010 subjects
Withdrawal Of Consent		FG0001 subjects FG0010 subjects
Exceeded 12 Weeks Of Run In		FG0002 subjects FG0010 subjects
Not treated with Patiromer during Run-in		FG00027 subjects FG0010 subjects

Treatment Phase (Overall Study)

Type	Comment	Milestone Data
STARTED		FG000439 subjects FG001439 subjects
COMPLETED		FG000360 subjects FG001367 subjects
NOT COMPLETED		FG00079 subjects FG00172 subjects

Type	Comment	Reasons
Protocol Violation		FG0000 subjects FG0011 subjects
Physician Decision		FG00020 subjects FG001

Arm/Group Information

ID	Title	Description
BG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
BG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00066.6± 10.0 BG00167.1± 9.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000112 BG001126 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00056 BG00157 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00016 BG00116 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Changes in Serum K+ Levels From Baseline

Adjusted mean changes in serum K+ from Baseline.

Posted

Least Squares Mean

Standard Error

Milliequivalents Per Liter (mEq/l)

Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

ID	Title	Description
OG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
OG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Units	Counts
Participants	OG000439 OG001439

Title

Denominators

Categories

Title	Measurements
	OG0000.029± 0.019 OG0010.127± 0.019

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Difference in adjusted mean changes (SE)	Mixed model for repeated measures (MMRM)		< 0.001		Mean Difference (Final Values)	-0.097	Standard Error of the Mean	0.015	2-Sided	95	-0.128	-0.067					Superiority

Secondary

CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time

Cumulative incidence of the first event of hyperkalemia with a serum K+ value >5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time.

Aalen-Johansen estimators of the cumulative incidence function with death as a competing event.

CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter

Posted

Number

95% Confidence Interval

Probability

From Day 1/Baseline to week 90

ID	Title	Description
OG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
OG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Secondary

CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time

Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time.

Note: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint.

CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter

Posted

Number

95% Confidence Interval

Probability

From Day 1/Baseline to week 102

ID	Title	Description
OG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
OG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Secondary

Investigator-reported Events of Hyperkalemia

Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first.

Annualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.

Posted

Number

Ann. event rate per 100 subject-years

Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

ID	Title	Description
OG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
OG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Secondary

Hyperkalemia-related Hard Outcomes Endpoints

Analyzed using Win Ratio approach with the following hierarchical components:

Time to CV death
Total number of CV hospitalizations
Total number of hyperkalemia toxicity events with serum K+ >6.5 mEq/l
Total number of hyperkalemia events with serum K+ >6.0-6.5 mEq/l
Total number of hyperkalemia events with serum K+ >5.0 mEq/l

MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular

Posted

Number

Events

Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

ID	Title	Description
OG000	All Participants	All participants randomized to patiromer or placebo arm.

Units	Counts
Participants	OG000

Secondary

RAASi Use Score

RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components:

All-cause death
Occurrence of a CV hospitalization
HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker

Each participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point.

RAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.

Posted

Number

Events

Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

ID	Title	Description
OG000	All Participants	All participants randomized to patiromer or placebo arm.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Patiromer	Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).	24	439	54	439	320	439
EG001	Placebo	Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase. The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).	18	439	58	439	325	439

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peripheral ischaemia	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Hypotension	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0012 events2 affected439 at risk
Pancoast's tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Sudden death	General disorders	MedDRA (23.0)	Systematic Assessment	EG00010 events10 affected439 at risk EG00110 events10 affected439 at risk
Death	General disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Ultrasound pancreas abnormal	Investigations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Cardiac failure	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG00010 events9 affected439 at risk EG00118 events15 affected439 at risk
Angina unstable	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0003 events3 affected439 at risk EG0013 events3 affected439 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0010 events0 affected439 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0012 events2 affected439 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events1 affected439 at risk EG0011 events1 affected439 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0012 events1 affected439 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Angina pectoris	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Left ventricular failure	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events1 affected439 at risk EG0010 events0 affected439 at risk
Myocardial infarction	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Cardiac arrest	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Coronary artery disease	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0012 events1 affected439 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0016 events4 affected439 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events1 affected439 at risk EG0010 events0 affected439 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Vocal cord dysfunction	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0014 events3 affected439 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0011 events1 affected439 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Cerebral infarction	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Brain injury	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Status epilepticus	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Vomiting	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Renal failure	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0010 events0 affected439 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0011 events1 affected439 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk
Pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0005 events5 affected439 at risk EG0016 events6 affected439 at risk
COVID-19	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0013 events3 affected439 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Cellulitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected439 at risk EG0010 events0 affected439 at risk
Gangrene	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0012 events2 affected439 at risk
Endocarditis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0011 events1 affected439 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypotension	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG00017 events15 affected439 at risk EG00114 events13 affected439 at risk
Hypertension	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0008 events8 affected439 at risk EG0012 events2 affected439 at risk
Asthenia	General disorders	MedDRA (23.0)	Systematic Assessment	EG0005 events5 affected439 at risk EG0019 events8 affected439 at risk
Oedema peripheral	General disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0015 events5 affected439 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events6 affected439 at risk EG0010 events0 affected439 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (23.0)	Systematic Assessment	EG00019 events15 affected439 at risk EG00114 events10 affected439 at risk
Blood creatinine increased	Investigations	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0015 events5 affected439 at risk
Cardiac failure	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG00011 events10 affected439 at risk EG00111 events10 affected439 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events5 affected439 at risk EG0013 events3 affected439 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (23.0)	Systematic Assessment	EG00011 events11 affected439 at risk EG0016 events5 affected439 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (23.0)	Systematic Assessment	EG0009 events9 affected439 at risk EG0017 events7 affected439 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0007 events6 affected439 at risk EG0012 events2 affected439 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events5 affected439 at risk EG0010 events0 affected439 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0004 events4 affected439 at risk EG0017 events5 affected439 at risk
Headache	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0009 events9 affected439 at risk EG00114 events11 affected439 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG00020 events19 affected439 at risk EG00115 events15 affected439 at risk
Constipation	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG00013 events11 affected439 at risk EG0015 events5 affected439 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected439 at risk EG0015 events5 affected439 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0007 events5 affected439 at risk EG0018 events8 affected439 at risk
Renal impairment	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0005 events5 affected439 at risk EG0017 events7 affected439 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG00011 events10 affected439 at risk EG0016 events6 affected439 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events6 affected439 at risk EG0013 events3 affected439 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG000335 events197 affected439 at risk EG001412 events238 affected439 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG00075 events66 affected439 at risk EG00153 events47 affected439 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG00020 events19 affected439 at risk EG00125 events22 affected439 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG00011 events10 affected439 at risk EG0013 events3 affected439 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0007 events7 affected439 at risk EG0015 events5 affected439 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events6 affected439 at risk EG0012 events2 affected439 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0015 events5 affected439 at risk
Pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0008 events7 affected439 at risk EG0011 events1 affected439 at risk
COVID-19	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0006 events6 affected439 at risk EG0018 events6 affected439 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected439 at risk EG0016 events6 affected439 at risk

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Title

Denominators

Categories

Week 1

Title	Measurements
	OG0000.02(0.01 to 0.04) OG0010.04(0.03 to 0.06)

Week 2

Title	Measurements
	OG0000.04(0.02 to 0.06) OG0010.08(0.06 to 0.11)

Week 6

Title	Measurements
	OG0000.05(0.03 to 0.07) OG0010.10(0.08 to 0.13)

Week 18

Title	Measurements
	OG0000.08(0.06 to 0.12) OG0010.14(0.11 to 0.18)

Week 30

Title	Measurements
	OG0000.13(0.10 to 0.17) OG0010.20(0.15 to 0.24)

Week 42

Title	Measurements
	OG0000.17(0.12 to 0.22) OG0010.24(0.19 to 0.29)

Week 54

Title	Measurements
	OG0000.21(0.15 to 0.27) OG0010.29(0.23 to 0.35)

Week 66

Title	Measurements
	OG0000.25(0.18 to 0.32) OG0010.34(0.26 to 0.42)

Week 78

Title	Measurements
	OG0000.30(0.22 to 0.40) OG0010.34(0.26 to 0.42)

Week 90

Title	Measurements
	OG0000.34(0.23 to 0.44) OG0010.34(0.26 to 0.42)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hazard Ratio patiromer vs placebo. The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate	Regression, Cox		= 0.006	Threshold for statistical significance = 0.05	Hazard Ratio (HR)	0.63			2-Sided	95	0.45	0.87					Superiority

Title

Denominators

Categories

Week 1

Title	Measurements
	OG0000.02(0.01 to 0.04) OG0010.04(0.03 to 0.07)

Week 2

Title	Measurements
	OG0000.03(0.02 to 0.05) OG0010.08(0.06 to 0.11)

Week 6

Title	Measurements
	OG0000.06(0.04 to 0.08) OG0010.12(0.09 to 0.15)

Week 18

Title	Measurements
	OG0000.10(0.08 to 0.14) OG0010.15(0.12 to 0.19)

Week 30

Title	Measurements
	OG0000.14(0.10 to 0.18) OG0010.19(0.15 to 0.23)

Week 42

Title	Measurements
	OG0000.16(0.12 to 0.21) OG0010.23(0.18 to 0.28)

Week 54

Title	Measurements
	OG0000.19(0.14 to 0.24) OG0010.26(0.20 to 0.32)

Week 66

Title	Measurements
	OG0000.22(0.16 to 0.29) OG0010.27(0.21 to 0.33)

Week 78

Title	Measurements
	OG0000.27(0.20 to 0.35) OG0010.29(0.22 to 0.36)

Week 90

Title	Measurements
	OG0000.27(0.20 to 0.35) OG0010.29(0.22 to 0.36)

Week 102

Title	Measurements
	OG0000.27(0.20 to 0.35) OG001NA(0 to 0)Not feasible to estimate the cumulative incidence at a time beyond the largest observed time

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hazard Ratio patiromer vs placebo. The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate	Regression, Cox		= 0.006	Threshold for statistical significance = 0.05	Hazard Ratio (HR)	0.62			2-Sided	95	0.45	0.87					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	NBMAC Annualized event RR patiromer vs placebo. NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer. NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate	Negative binomial model adjusted for cov		< 0.001		Annualized event rate ratio	0.658			2-Sided	95	0.534	0.81					Superiority

Title

Denominators

Categories

CV death in Placebo Group First

Title	Measurements
	OG0003491

CV death in Patiromer Group First

Title	Measurements
	OG0004609

More CV hospitalizations in Placebo Group

Title	Measurements
	OG0004539

More CV hospitalizations in Patiromer Group

Title	Measurements
	OG0004178

MHTE with serum K+>6.5 in Placebo Group

Title	Measurements
	OG000419

MHTE with serum K+>6.5 in Patiromer Group

Title	Measurements
	OG000401

MHE with serum K+>6.0-6.5 in Placebo Group

Title	Measurements
	OG0004283

MHE with serum K+>6.0-6.5 in Patiromer Group

Title	Measurements
	OG0001446

MHE with serum K+>5.0-6.0 in Placebo Group

Title	Measurements
	OG00055633

MHE with serum K+>5.0-6.0 in Patiromer Group

Title	Measurements
	OG00034156

None of the above

Title	Measurements
	OG00079566

Total number of pairs

Title	Measurements
	OG000192721

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Win ratio for composite. Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers.	Win Ratio		<0.001		Win Ratio	1.526			2-Sided	95	1.231	1.906					Superiority
OG000	Win ratio CV death and hospitalization. Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer.	Win Ratio		= 0.744		Win Ratio	0.914			2-Sided	95	0.526	1.578					Superiority

Title

Denominators

Categories

Number of wins in Patiromer Group

Title	Measurements
	OG00062073

Number of wins in Placebo Group

Title	Measurements
	OG00049733

Number of ties

Title	Measurements
	OG00080915

Total number of pairs

Title	Measurements
	OG000192721

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Win ratio for composite. Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer.	Win Ratio		= 0.048		Win Ratio	1.248			2-Sided	95	1.003	1.564					Superiority

ID	Term
D006947	Hyperkalemia
D051436	Renal Insufficiency, Chronic
D006973	Hypertension
D006333	Heart Failure