Effect of SNF472 on Progression of Cardiovascular Calcifi... | NCT02966028

Name	Class
Clinipace Worldwide	INDUSTRY

Label	Type	Description	Intervention Names
SNF472 300 mg	Experimental	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)	Drug: SNF472
SNF 472 600 mg	Experimental	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)	Drug: SNF472
Matching Placebo	Placebo Comparator	Placebo arm: 2 vials of physiological saline	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SNF472	Drug	Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.	SNF 472 600 mg SNF472 300 mg

Measure	Description	Time Frame
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo	Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.	Baseline (Week 1, Day 1) and Week 52

Measure	Description	Time Frame
Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo	Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.

Name	Affiliation	Role
Alex Gold, MD	Sanifit Chief Medical Officer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Bakersfield	California	93308	United States

PubMed Identifier	Type	Citation	Retractions
38384289	Derived	Perello J, Alberti J, Torres JV, Ferrer MD, Perez MM, Bassissi F, Gold A, Raggi P, Chertow GM, Salcedo C. Hexasodium fytate exposure-response correlations in a randomized, placebo-controlled study of patients on dialysis with cardiovascular calcification. Front Pharmacol. 2024 Feb 7;15:1325186. doi: 10.3389/fphar.2024.1325186. eCollection 2024.
33835939

ID	Title	Description
FG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
FG001	SNF 472 600 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 1, 2019	Aug 23, 2020

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

Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.

A smaller change from baseline to follow up is a better outcome.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg & 600 mg Combined	Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	Matching Placebo	Placebo arm: 2 vials of physiological saline Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Units	Counts
Participants	OG000142 OG00177

Title

Denominators

Categories

Title	Measurements
	OG0001.11(1.067 to 1.153) OG0011.20(1.138 to 1.262)

Secondary

Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo

Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed.

A smaller change from baseline to follow up is a better outcome.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg

Secondary

Change in Log CAC Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and for the Combined Dose Groups vs the Placebo Group

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg

Secondary

Number of Subjects With <15% Progression in CAC Agatston Score From Baseline to Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo

Agatston score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 were calculated as a percentage of change (progression or worsening of calcification). The number of subjects with <15% progression were counted.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Count of Participants

Participants

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo

Agatston score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 was calculated as a percentage of change (progression or worsening of calcification). The number of subjects with >=15% progression were counted for each treatment group, the combined treatments groups and placebo.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Count of Participants

Participants

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Change in Log Thoracic Aorta Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the thoracic aorta was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.

A smaller change from baseline to follow up is a better outcome.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001

Secondary

Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in CAC Agatston Score in the thoracic aorta from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Change in Log Aortic Valve Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the aortic valve was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.

A smaller change from baseline to follow up is a better outcome.

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score or the aortic valve from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.

Modified intent-to-treat (mITT) population, last observation carried forward (LOCF)

Posted

Geometric Least Squares Mean

95% Confidence Interval

ratio

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.

The number of subjects meeting this composite safety endpoint were counted and expressed by the randomized arm as a % of patients for the safety population.terms resulting in death from cardiovascular causes, myocardial infarction, stroke, or heart failure for each dose group and placebo were summarized .

Safety Population

Posted

Count of Participants

Participants

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG002	SNF 472 Combined Dose Groups	Doses 300 and 600 mg. 1 vial of physiological saline and 1 vial of active or 2 vials of active(10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Secondary

Mortality Rate (All-cause) for Each Dose Group and Placebo

The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population.

Safety Population

Posted

Count of Participants

Participants

Baseline (Week 1, Day 1) and Week 52

ID	Title	Description
OG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
OG002	SNF 472 Combined Dose Groups	Doses 300 and 600 mg. 1 vial of physiological saline and 1 vial of active or 2 vials of active(10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected92 at risk EG0013 events3 affected91 at risk EG0027 events7 affected90 at risk
Sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0012 events2 affected91 at risk EG0021 events1 affected90 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Septic shock	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Bronchitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Device related infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0012 events2 affected91 at risk EG0020 events0 affected90 at risk
Endocarditis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Gangrene	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0012 events2 affected91 at risk EG0020 events0 affected90 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous graft site abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Arthritis infective	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Diabetic foot infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Diverticulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Emphysematous cystitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Enterocolitis viral	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Herpes zoster	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Influenza	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Localised infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Pseudomonas infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Urosepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Vascular access site infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Wound infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Renal Transplant	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected92 at risk EG00114 events14 affected91 at risk EG00211 events11 affected90 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0013 events3 affected91 at risk EG0021 events1 affected90 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0012 events2 affected91 at risk EG0022 events2 affected90 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected92 at risk EG0013 events3 affected91 at risk EG0022 events2 affected90 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0024 events4 affected90 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0013 events3 affected91 at risk EG0020 events0 affected90 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0013 events3 affected91 at risk EG0020 events0 affected90 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Coronary artery disease	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Angina unstable	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Left ventricular failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0014 events4 affected91 at risk EG0020 events0 affected90 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Ascites	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Ulcerative gastritis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected92 at risk EG0012 events2 affected91 at risk EG0021 events1 affected90 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Haematoma	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0012 events2 affected91 at risk EG0020 events0 affected90 at risk
Aortic stenosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Foreign body embolism	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0023 events3 affected90 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0011 events1 affected91 at risk EG0022 events2 affected90 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Loss of consciousness	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Cognitive disorder	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Dizziness postural	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Epilepsy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Seizure	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Syncope	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0023 events3 affected90 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0013 events3 affected91 at risk EG0020 events0 affected90 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Asthenia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0022 events2 affected90 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Blood lactic acid increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Cardiac stress test abnormal	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Influenza a virus test positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
International normalised ratio increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Myocardial necrosis marker increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Stress echocardiogram abnormal	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Troponin increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0021 events1 affected90 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Retinal detachment	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Renal mass	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk EG0020 events0 affected90 at risk
Mental status changes	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk EG0020 events0 affected90 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Lymphadenectomy	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk
Toe amputation	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected92 at risk EG0010 events0 affected91 at risk EG0021 events1 affected90 at risk

ID	Term
D002318	Cardiovascular Diseases
D018376	Cardiovascular Abnormalities
D061205	Vascular Calcification
D007676	Kidney Failure, Chronic
D002114	Calcinosis

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D051436	Renal Insufficiency, Chronic
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

ID	Title	Description
BG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
BG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
BG002	Matching Placebo	Placebo arm: 2 vials of physiological saline Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SNF472 300 mg	Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.	1	92	38	92	62	92
EG001	SNF 472 600 mg	Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.	6	91	55	91	64	91
EG002	Matching Placebo	Placebo arm: 2 vials of physiological saline Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.	5	90	49	90	67	90