Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delive... | NCT01320202

Label	Type	Description	Intervention Names
Soluble Ferric Pyrophosphate (SFP) in dialysate	Active Comparator	11 micrograms (µg) of iron / deciliter (dL) of dialysate.	Drug: Soluble Ferric Pyrophosphate (SFP)
Standard Dialysate	Placebo Comparator	0 micrograms (µg) of iron / deciliter (dL) of dialysate.	Device: Standard dialysate

Name	Type	Description	Arm Group Labels	Other Names
Soluble Ferric Pyrophosphate (SFP)	Drug	Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.	Soluble Ferric Pyrophosphate (SFP) in dialysate

Measure	Description	Time Frame
Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean	Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.	Hgb measured weekly; up to 48 weeks from the date of randomization
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb	Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).	Hgb measured weekly; up to 48 weeks from the date of randomization

Measure	Description	Time Frame
Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.	The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

Name	Affiliation	Role
Ray Pratt, MD	Rockwell Medical	Study Director

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

PubMed Identifier	Type	Citation	Retractions
26175145	Derived	Fishbane SN, Singh AK, Cournoyer SH, Jindal KK, Fanti P, Guss CD, Lin VH, Pratt RD, Gupta A. Ferric pyrophosphate citrate (Triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015 Dec;30(12):2019-26. doi: 10.1093/ndt/gfv277. Epub 2015 Jul 13.

ID	Title	Description
FG000	Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
FG001	Standard Dialysate

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 From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean

Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.

modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.

Posted

Least Squares Mean

Standard Error

grams per liter

Hgb measured weekly; up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Units	Counts
Participants	OG000148 OG001151

Title

Denominators

Categories

Title	Measurements
	OG0000.6± 1.15 OG001-3.0± 1.14

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		ANCOVA		0.011	LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.	Difference in LS Means between SFP & PBO	3.6	Standard Error of the Mean	1.40	2-Sided								Superiority or Other

Secondary

Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.

The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

micromoles per liter

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Secondary

Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.

The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

percent

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Secondary

Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.

The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.

modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

micromole per liter

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Secondary

Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion

The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.

Intent-to-Treat (ITT): all patients randomized are included.

Posted

Number

participants

up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units	Counts

Secondary

Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused

The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.

Intent-to-Treat (ITT): all patients randomized are included.

Posted

Number

units of red blood cells or whole blood

up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Secondary

Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel

A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).

modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

percentage of change

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Secondary

Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.

modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

micromoles per liter

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units

Secondary

Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.

modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

picograms

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units	Counts
Participants

Secondary

Change From Baseline to End-of-Treatment (EoT) in Ferritin

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.

modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

micrograms per liter

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units	Counts
Participants

Secondary

Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.

modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

grams per liter

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units	Counts
Participants

Secondary

Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.

modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

percentage of saturation

Up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Units	Counts
Participants

Secondary

Variability of Hemoglobin Concentration: Temporal Trend

The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.

modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

grams per liter per week

Hgb measured weekly; up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Units	Counts
Participants

Secondary

Variability of Hemoglobin Concentration: Residual Standard Deviation

The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.

modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

grams per liter

Hgb measured weekly; up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Units	Counts
Participants

Primary

Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb

Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).

modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

grams per liter

Hgb measured weekly; up to 48 weeks from the date of randomization

ID	Title	Description
OG000	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.
OG001	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ABDOMINAL PAIN	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ACCELERATED HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0003 events3 affected151 at risk EG0013 events3 affected149 at risk EG0021 events1 affected205 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ADVERSE DRUG REACTION	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected149 at risk EG0021 events1 affected205 at risk
ANAEMIA OF CHRONIC DISEASE	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ANGINA PECTORIS	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0023 events3 affected205 at risk
ANGINA UNSTABLE	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ANXIETY	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ARTERIOSCLEROSIS	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0023 events1 affected205 at risk
ARTERIOVENOUS FISTULA ANEURYSM	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ARTERIOVENOUS FISTULA OCCLUSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ARTERIOVENOUS FISTULA SITE HAEMATOMA	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0021 events1 affected205 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG0024 events4 affected205 at risk
ARTERIOVENOUS GRAFT SITE INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0023 events3 affected205 at risk
ATRIAL FLUTTER	Cardiac disorders	Systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
BACTERAEMIA	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
CARDIAC ARREST	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG0025 events5 affected205 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	Systematic Assessment	EG0008 events5 affected151 at risk EG0012 events1 affected149 at risk EG0028 events4 affected205 at risk
CARDIOGENIC SHOCK	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CARDIOMYOPATHY	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
CARDIOVERSION	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CATHETER SITE HAEMATOMA	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CELLULITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected149 at risk EG0022 events2 affected205 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
CERVIX CARCINOMA STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CHEST PAIN	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CHILLS	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
CHOLANGITIS	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
COLORECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
COMMINUTED FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
CONVULSION	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG0023 events3 affected205 at risk
CROHN'S DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DEATH	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
DEHYDRATION	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DEVICE DISLOCATION	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DEVICE RELATED INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
DIABETIC FOOT	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DIARRHOEA	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
DIVERTICULITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DIZZINESS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
DYSPHAGIA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ENDOCARDITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
ENDOMETRIAL HYPERPLASIA	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	Systematic Assessment	EG00012 events10 affected151 at risk EG0012 events2 affected149 at risk EG0025 events5 affected205 at risk
GANGRENE	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
GASTRITIS	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0021 events1 affected205 at risk
GASTROENTERITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0023 events3 affected205 at risk
GASTROENTERITIS VIRAL	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0023 events3 affected205 at risk
HAEMANGIOMA OF LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
HEAD INJURY	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
HEADACHE	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0021 events1 affected205 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0007 events4 affected151 at risk EG0010 events0 affected149 at risk EG00211 events9 affected205 at risk
HYPERPARATHYROIDISM SECONDARY	Endocrine disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0025 events5 affected205 at risk
HYPERTENSIVE CRISIS	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0024 events4 affected205 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
HYPOTENSION	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
INFECTED SKIN ULCER	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
LOBAR PNEUMONIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0023 events3 affected205 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
NON-CARDIAC CHEST PAIN	General disorders	Systematic Assessment	EG0005 events5 affected151 at risk EG0011 events1 affected149 at risk EG0023 events3 affected205 at risk
OESOPHAGEAL ULCER HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
OSTEOMYELITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PANCREATITIS	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0012 events1 affected149 at risk EG0020 events0 affected205 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events1 affected205 at risk
PNEUMONIA	Infections and infestations	Systematic Assessment	EG0005 events5 affected151 at risk EG0014 events4 affected149 at risk EG00210 events5 affected205 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
PORTAL HYPERTENSIVE GASTROPATHY	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PROCEDURAL HYPERTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0022 events2 affected205 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
PYREXIA	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
RENAL CYST HAEMORRHAGE	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
RENAL CYST INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
SEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0024 events4 affected205 at risk
SHOCK	Vascular disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0023 events3 affected205 at risk
STENT-GRAFT ENDOLEAK	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
SUDDEN DEATH	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
SYNCOPE	Nervous system disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG0023 events3 affected205 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
TOXICITY TO VARIOUS AGENTS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0020 events0 affected205 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected149 at risk EG0022 events2 affected205 at risk
UROSEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
VASCULAR GRAFT THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0026 events4 affected205 at risk
VIRAL INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected151 at risk EG0010 events0 affected149 at risk EG0021 events1 affected205 at risk
VOMITING	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected149 at risk EG0020 events0 affected205 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected151 at risk EG0013 events3 affected149 at risk EG0027 events7 affected205 at risk
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG00010 events7 affected151 at risk EG0014 events3 affected149 at risk EG00211 events11 affected205 at risk
ANGINA PECTORIS	Cardiac disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG0027 events7 affected205 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG00023 events19 affected151 at risk EG00130 events17 affected149 at risk EG00258 events25 affected205 at risk
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected151 at risk EG0018 events4 affected149 at risk EG00214 events7 affected205 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected151 at risk EG0012 events2 affected149 at risk EG00210 events7 affected205 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected151 at risk EG0019 events6 affected149 at risk EG00217 events15 affected205 at risk
ASTHENIA	General disorders	Systematic Assessment	EG0007 events7 affected151 at risk EG0017 events7 affected149 at risk EG0029 events9 affected205 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected151 at risk EG0016 events5 affected149 at risk EG00216 events13 affected205 at risk
CONSTIPATION	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected149 at risk EG00212 events11 affected205 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00011 events10 affected151 at risk EG00114 events11 affected149 at risk EG00227 events21 affected205 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events4 affected151 at risk EG0010 events0 affected149 at risk EG0028 events8 affected205 at risk
DIARRHOEA	Gastrointestinal disorders	Systematic Assessment	EG00017 events15 affected151 at risk EG00114 events13 affected149 at risk EG00245 events30 affected205 at risk
DIZZINESS	Nervous system disorders	Systematic Assessment	EG00016 events14 affected151 at risk EG00117 events13 affected149 at risk EG00252 events26 affected205 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events7 affected151 at risk EG0018 events6 affected149 at risk EG00234 events22 affected205 at risk
FATIGUE	General disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0017 events7 affected149 at risk EG0022 events2 affected205 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events2 affected151 at risk EG0017 events5 affected149 at risk EG00215 events8 affected205 at risk
HAEMODIALYSIS-INDUCED SYMPTOM	Injury, poisoning and procedural complications	Systematic Assessment	EG0009 events5 affected151 at risk EG00111 events7 affected149 at risk EG002199 events39 affected205 at risk
HEADACHE	Nervous system disorders	Systematic Assessment	EG0009 events8 affected151 at risk EG00116 events14 affected149 at risk EG00253 events38 affected205 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected151 at risk EG0016 events4 affected149 at risk EG0027 events7 affected205 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0013 events3 affected149 at risk EG0029 events8 affected205 at risk
HYPOAESTHESIA	Nervous system disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0017 events5 affected149 at risk EG0025 events5 affected205 at risk
INSOMNIA	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected149 at risk EG0027 events7 affected205 at risk
MALAISE	General disorders	Systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected149 at risk EG00210 events9 affected205 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00020 events11 affected151 at risk EG00115 events7 affected149 at risk EG00233 events10 affected205 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0014 events2 affected149 at risk EG00216 events13 affected205 at risk
NASOPHARYNGITIS	Infections and infestations	Systematic Assessment	EG0009 events6 affected151 at risk EG0012 events2 affected149 at risk EG0029 events9 affected205 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG00025 events14 affected151 at risk EG00113 events11 affected149 at risk EG00231 events20 affected205 at risk
NON-CARDIAC CHEST PAIN	General disorders	Systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected149 at risk EG0029 events9 affected205 at risk
OEDEMA PERIPHERAL	General disorders	Systematic Assessment	EG0007 events6 affected151 at risk EG00112 events8 affected149 at risk EG00227 events14 affected205 at risk
PAIN	General disorders	Systematic Assessment	EG0004 events4 affected151 at risk EG0012 events2 affected149 at risk EG00211 events10 affected205 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events7 affected151 at risk EG00118 events13 affected149 at risk EG00213 events13 affected205 at risk
PROCEDURAL DIZZINESS	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected151 at risk EG0014 events1 affected149 at risk EG0029 events7 affected205 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG000216 events41 affected151 at risk EG001174 events43 affected149 at risk EG002494 events68 affected205 at risk
PYREXIA	General disorders	Systematic Assessment	EG0004 events4 affected151 at risk EG00112 events7 affected149 at risk EG00211 events10 affected205 at risk
THROMBOSIS IN DEVICE	General disorders	Systematic Assessment	EG0006 events5 affected151 at risk EG0013 events3 affected149 at risk EG00215 events6 affected205 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0006 events5 affected151 at risk EG0014 events4 affected149 at risk EG0026 events5 affected205 at risk
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0002 events2 affected151 at risk EG0018 events7 affected149 at risk EG0025 events3 affected205 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected151 at risk EG0018 events4 affected149 at risk EG00225 events13 affected205 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected149 at risk EG00234 events9 affected205 at risk
VOMITING	Gastrointestinal disorders	Systematic Assessment	EG00016 events12 affected151 at risk EG0016 events5 affected149 at risk EG00218 events16 affected205 at risk

ID	Term
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	Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
BG001	Standard Dialysate	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Stage 2 Placebo (Standard Dialysate)	0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.	45	151	100	151
EG001	Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.	36	149	96	149
EG002	Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate	11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3).	81	205	148	205