Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delive... | NCT01322347

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, along with standard error.	Hgb measured weekly; up to 48 weeks from date of randomization
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin	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 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
Investigator		Paragould	Arkansas	72450	United States
Investigator

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 (Placebo)

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, along with standard error.

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

Posted

Least Squares Mean

Standard Error

grams per liter

Hgb measured weekly; up to 48 weeks from 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	OG000142 OG001144

Title

Denominators

Categories

Title	Measurements
	OG000-0.5± 1.08 OG001-4.0± 1.09

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	1.39	2-Sided	95							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: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.

Posted

Mean

Standard Deviation

micromoles per liter

Up to 48 weeks from 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 Transferrin Saturation 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 received 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 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-Dialysis 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 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 Who Received a 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: all randomized subjects

Posted

Number

participants

Up to 48 weeks from 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

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: all randomized subjects

Posted

Number

units of red blood cells or whole blood

Up to 48 weeks from 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

Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the 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 from baseline

up to 48 weeks from 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

Change From 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)

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 medication and had at least one post-dose hemoglobin measured.

Posted

Mean

Standard Deviation

micromoles per liter

Up to 48 weeks from 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

Secondary

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

The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)

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

picograms

Up to 48 weeks from 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

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

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

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

micrograms per liter

Up to 48 weeks from 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

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

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

Up to 48 weeks from 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

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)

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

percentage

Up to 48 weeks from 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: 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

up to 48 weeks from 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 the hemoglobin concentration 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

up to 48 weeks from 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 Hemoglobin

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 subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.

Posted

Mean

Standard Deviation

grams per liter

Hgb measured weekly; up to 48 weeks from 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.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0003 events3 affected145 at risk EG0010 events0 affected143 at risk EG0024 events4 affected214 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0023 events3 affected214 at risk
ADVERSE DRUG REACTION	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0023 events3 affected214 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
ANGINA PECTORIS	Cardiac disorders	Systematic Assessment	EG0003 events2 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
ANGINA UNSTABLE	Cardiac disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
ANXIETY	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
AORTIC DISSECTION	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
AORTIC STENOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
APPENDICITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
ARTERIOVENOUS FISTULA SITE INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected145 at risk EG0013 events3 affected143 at risk EG0024 events4 affected214 at risk
ARTERIOVENOUS GRAFT SITE HAEMORRHAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
ARTERIOVENOUS GRAFT SITE INFECTION	Infections and infestations	Systematic Assessment	EG0002 events2 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
ASCITES	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0011 events1 affected143 at risk EG0028 events8 affected214 at risk
BACTERAEMIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
BILIARY COLIC	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
BRONCHITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
BRONCHOPNEUMONIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
CARDIAC ABLATION	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
CARDIAC ARREST	Cardiac disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG0024 events4 affected214 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	Systematic Assessment	EG0003 events2 affected145 at risk EG0015 events4 affected143 at risk EG0025 events4 affected214 at risk
CARDIAC NEOPLASM UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CARDIOGENIC SHOCK	Cardiac disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
CARDIOMYOPATHY	Cardiac disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
CATHETER SITE HAEMORRHAGE	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
CELLULITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0024 events4 affected214 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CHEST PAIN	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CHOLELITHIASIS	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0022 events2 affected214 at risk
COAGULOPATHY	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
COLONIC POLYP	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CONFUSIONAL STATE	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
CONGENITAL CYSTIC KIDNEY DISEASE	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CONSTIPATION	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0010 events0 affected143 at risk EG0023 events3 affected214 at risk
DEATH	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
DEPRESSION	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
DEVICE RELATED SEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG0023 events3 affected214 at risk
DIABETIC FOOT	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
DIABETIC FOOT INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0014 events3 affected143 at risk EG0022 events2 affected214 at risk
DIABETIC GASTROPARESIS	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0022 events1 affected214 at risk
DIARRHOEA	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0023 events3 affected214 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
EXSANGUINATION	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events3 affected145 at risk EG0013 events3 affected143 at risk EG00212 events10 affected214 at risk
FRACTURE DISPLACEMENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events1 affected214 at risk
GANGRENE	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0026 events5 affected214 at risk
GASTRIC ULCER	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
GASTROENTERITIS VIRAL	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
GASTROINTESTINAL STOMA COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
HYDROCEPHALUS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0012 events2 affected143 at risk EG0029 events7 affected214 at risk
HYPERPARATHYROIDISM SECONDARY	Endocrine disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
HYPERTENSIVE CRISIS	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
HYPERVOLAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0024 events4 affected214 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
HYPOTENSION	Vascular disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0022 events2 affected214 at risk
HYPOTHYROIDISM	Endocrine disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
INCISION SITE PAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
INFLUENZA	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
INGUINAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
JOINT ABSCESS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
KLEBSIELLA SEPSIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
LOBAR PNEUMONIA	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
MALAISE	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events1 affected143 at risk EG0020 events0 affected214 at risk
MALIGNANT HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0024 events2 affected214 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
NECROTISING FASCIITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
NEPHROLITHIASIS	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
NEUROGLYCOPENIA	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
NON-CARDIAC CHEST PAIN	General disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0012 events2 affected143 at risk EG0026 events6 affected214 at risk
OBESITY SURGERY	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
OSTEOMYELITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0025 events3 affected214 at risk
PALPITATIONS	Cardiac disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
PANCREATITIS	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
PANCREATITIS CHRONIC	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events1 affected143 at risk EG0020 events0 affected214 at risk
PANCREATITIS RELAPSING	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PNEUMONIA	Infections and infestations	Systematic Assessment	EG0003 events3 affected145 at risk EG0012 events2 affected143 at risk EG0025 events4 affected214 at risk
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
POSTOPERATIVE ILEUS	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0025 events4 affected214 at risk
PROCEDURAL NAUSEA	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG0020 events0 affected214 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PSEUDOMONAL BACTERAEMIA	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0014 events4 affected143 at risk EG0027 events7 affected214 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
PYREXIA	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
RENAL CYST HAEMORRHAGE	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
REVERSAL OF ILEOJEJUNAL BYPASS	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
SEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
SEPSIS SYNDROME	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
SEPTIC SHOCK	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
STATUS EPILEPTICUS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
SUDDEN DEATH	General disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
SYNCOPE	Nervous system disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
TEMPORAL ARTERITIS	Vascular disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
TESTIS CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
TROPONIN INCREASED	Investigations	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0020 events0 affected214 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0022 events2 affected214 at risk
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
UROSEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0021 events1 affected214 at risk
URTICARIA	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0010 events0 affected143 at risk EG0021 events1 affected214 at risk
VASCULAR GRAFT THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
VERTEBROBASILAR INSUFFICIENCY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk
VOMITING	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0020 events0 affected214 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0014 events2 affected143 at risk EG00210 events9 affected214 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0015 events5 affected143 at risk EG00211 events7 affected214 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected145 at risk EG0013 events3 affected143 at risk EG0028 events7 affected214 at risk
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0013 events3 affected143 at risk EG00221 events17 affected214 at risk
ANGINA PECTORIS	Cardiac disorders	Systematic Assessment	EG0003 events2 affected145 at risk EG0012 events1 affected143 at risk EG00213 events11 affected214 at risk
ANXIETY	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected145 at risk EG0011 events1 affected143 at risk EG0028 events7 affected214 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG00021 events14 affected145 at risk EG00119 events15 affected143 at risk EG00285 events52 affected214 at risk
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0006 events2 affected145 at risk EG0017 events6 affected143 at risk EG00218 events12 affected214 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0012 events2 affected143 at risk EG00216 events14 affected214 at risk
ASTHENIA	General disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0015 events4 affected143 at risk EG00220 events17 affected214 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events6 affected145 at risk EG0016 events6 affected143 at risk EG00220 events17 affected214 at risk
BRADYCARDIA	Cardiac disorders	Systematic Assessment	EG0006 events4 affected145 at risk EG00110 events4 affected143 at risk EG00215 events7 affected214 at risk
BRONCHITIS	Infections and infestations	Systematic Assessment	EG0002 events2 affected145 at risk EG0015 events5 affected143 at risk EG0024 events4 affected214 at risk
CELLULITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0027 events7 affected214 at risk
CHILLS	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG00213 events8 affected214 at risk
CONSTIPATION	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0015 events5 affected143 at risk EG00219 events18 affected214 at risk
CONTUSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0006 events6 affected145 at risk EG0016 events6 affected143 at risk EG00212 events9 affected214 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00015 events14 affected145 at risk EG00113 events10 affected143 at risk EG00223 events18 affected214 at risk
DIARRHOEA	Gastrointestinal disorders	Systematic Assessment	EG00014 events12 affected145 at risk EG00112 events10 affected143 at risk EG00262 events35 affected214 at risk
DIZZINESS	Nervous system disorders	Systematic Assessment	EG00011 events8 affected145 at risk EG00119 events9 affected143 at risk EG00245 events34 affected214 at risk
DYSPEPSIA	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected145 at risk EG0015 events5 affected143 at risk EG0026 events6 affected214 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected145 at risk EG00111 events11 affected143 at risk EG00236 events28 affected214 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected145 at risk EG0012 events2 affected143 at risk EG00210 events8 affected214 at risk
FACE OEDEMA	General disorders	Systematic Assessment	EG0003 events3 affected145 at risk EG0013 events2 affected143 at risk EG00215 events12 affected214 at risk
FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0014 events4 affected143 at risk EG0029 events7 affected214 at risk
FATIGUE	General disorders	Systematic Assessment	EG0004 events4 affected145 at risk EG0014 events4 affected143 at risk EG00215 events14 affected214 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events7 affected145 at risk EG0017 events5 affected143 at risk EG00245 events19 affected214 at risk
HAEMODIALYSIS-INDUCED SYMPTOM	Injury, poisoning and procedural complications	Systematic Assessment	EG00019 events9 affected145 at risk EG00114 events10 affected143 at risk EG002183 events58 affected214 at risk
HEADACHE	Nervous system disorders	Systematic Assessment	EG0009 events8 affected145 at risk EG00123 events13 affected143 at risk EG00261 events40 affected214 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected145 at risk EG0015 events5 affected143 at risk EG00221 events21 affected214 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0016 events5 affected143 at risk EG0028 events8 affected214 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events4 affected145 at risk EG0015 events5 affected143 at risk EG00210 events7 affected214 at risk
HYPOTENSION	Vascular disorders	Systematic Assessment	EG0005 events4 affected145 at risk EG0015 events5 affected143 at risk EG00211 events10 affected214 at risk
INSOMNIA	Psychiatric disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0012 events2 affected143 at risk EG0027 events7 affected214 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0008 events5 affected145 at risk EG0019 events8 affected143 at risk EG0026 events4 affected214 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected145 at risk EG0011 events1 affected143 at risk EG0029 events8 affected214 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG0027 events7 affected214 at risk
NASOPHARYNGITIS	Infections and infestations	Systematic Assessment	EG00011 events9 affected145 at risk EG0016 events5 affected143 at risk EG00212 events11 affected214 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG00019 events15 affected145 at risk EG00121 events11 affected143 at risk EG00274 events46 affected214 at risk
NON-CARDIAC CHEST PAIN	General disorders	Systematic Assessment	EG0004 events4 affected145 at risk EG0012 events2 affected143 at risk EG00210 events9 affected214 at risk
OEDEMA PERIPHERAL	General disorders	Systematic Assessment	EG0004 events3 affected145 at risk EG00114 events12 affected143 at risk EG00249 events31 affected214 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG00211 events7 affected214 at risk
PAIN	General disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG00226 events20 affected214 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 events9 affected145 at risk EG0017 events7 affected143 at risk EG00228 events24 affected214 at risk
PROCEDURAL DIZZINESS	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events2 affected145 at risk EG0017 events4 affected143 at risk EG00220 events8 affected214 at risk
PROCEDURAL HEADACHE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected145 at risk EG0011 events1 affected143 at risk EG00214 events8 affected214 at risk
PROCEDURAL HYPERTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected145 at risk EG0011 events1 affected143 at risk EG00226 events12 affected214 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	Systematic Assessment	EG00067 events16 affected145 at risk EG001143 events19 affected143 at risk EG002567 events75 affected214 at risk
PROCEDURAL NAUSEA	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events2 affected145 at risk EG0011 events1 affected143 at risk EG00218 events13 affected214 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected145 at risk EG0013 events3 affected143 at risk EG00220 events17 affected214 at risk
PRURITUS	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected145 at risk EG0012 events2 affected143 at risk EG00210 events10 affected214 at risk
PYREXIA	General disorders	Systematic Assessment	EG0005 events5 affected145 at risk EG0015 events5 affected143 at risk EG00223 events21 affected214 at risk
TACHYCARDIA	Cardiac disorders	Systematic Assessment	EG0005 events4 affected145 at risk EG00114 events1 affected143 at risk EG00211 events8 affected214 at risk
THROMBOSIS IN DEVICE	General disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0012 events2 affected143 at risk EG00214 events8 affected214 at risk
TOOTHACHE	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected145 at risk EG0013 events3 affected143 at risk EG00210 events7 affected214 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0008 events8 affected145 at risk EG00111 events8 affected143 at risk EG00216 events12 affected214 at risk
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected145 at risk EG0017 events5 affected143 at risk EG0026 events6 affected214 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0008 events4 affected145 at risk EG0013 events2 affected143 at risk EG00213 events11 affected214 at risk
VASCULAR GRAFT THROMBOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected145 at risk EG0010 events0 affected143 at risk EG0028 events7 affected214 at risk
VOMITING	Gastrointestinal disorders	Systematic Assessment	EG00016 events12 affected145 at risk EG00115 events11 affected143 at risk EG00246 events33 affected214 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 48 weeks.
BG001	Standard Dialysate (Placebo)	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.
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 Standard Dialysate (Placebo)	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.	36	145	93	145
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.	44	143	89	143
EG002	Stage 3 Soluble Ferric Pyrophosphate (SFP)	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).	83	214	179	214