A 58-Week Safety and Efficacy Trial of Ferric Citrate in... | NCT01191255

Label	Type	Description	Intervention Names
Active Control	Active Comparator	PhosLo (calcium acetate) Renvela (sevelamer carbonate)	Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
Placebo	Placebo Comparator	Placebo	Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
KRX-0502 (Ferric Citrate)	Experimental	ferric citrate	Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo

Name	Type	Description	Arm Group Labels	Other Names
ferric citrate, ca acetate, sevelamer carbonate, placebo	Drug	All intervention doses will be based on serum phosphorus levels and/or drug label requirements	Active Control

Measure	Description	Time Frame
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)	Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.	4 weeks

Measure	Description	Time Frame
Change in Mean Serum Ferritin From Baseline to Week 52		52 weeks
Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or non-pregnant, non-breast-feeding females
Age ≥18 years
On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
Serum phosphorus ≥6.0 mg/dL for study entry
Taking less than 3-18 pills/day of current phosphate binder
Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
Willing and able to give informed consent
Life expectancy >1 year

Exclusion Criteria:

Parathyroidectomy within six months prior to Screening
Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
History of multiple drug allergies or intolerances
History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
Previous intolerance to oral ferric citrate
Intolerance to oral iron-containing products
Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
Inability to tolerate oral drug intake
Intolerance to calcium acetate and sevelamer carbonate
Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
Inability to cooperate with study personnel or history of noncompliance
Unsuitable for this trial per Investigator's clinical judgment.

Name	Affiliation	Role
Julia B Lewis, MD	Collaborative Study Group	Study Chair
Samuel Blumenthal, MD	Collaborative Study Group	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Clinical Research Institute, LLC		Tempe	Arizona	85284	United States
Tower Nephrology Medical Group

PubMed Identifier	Type	Citation	Retractions
40576086	Derived	Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
26239948	Derived	Rodby RA, Umanath K, Niecestro R, Bond TC, Sika M, Lewis J, Dwyer JP; Collaborative Study Group. Ferric Citrate, an Iron-Based Phosphate Binder, Reduces Health Care Costs in Patients on Dialysis Based on Randomized Clinical Trial Data. Drugs R D. 2015 Sep;15(3):271-9. doi: 10.1007/s40268-015-0103-y.

ID	Title	Description
FG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
FG001	KRX-0502 (Ferric Citrate)-SAP

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)

Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.

Full Analysis Population (LOCF)

Posted

Mean

Standard Deviation

mg/dL

4 weeks

ID	Title	Description
OG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
OG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Units	Counts
Participants	OG0000 OG0010 OG00291 OG003

Title

Denominators

Categories

Baseline (Week 52)

Title	Measurements
	OG0025.44± 1.459 OG0035.12± 1.189

End of EAP (Week 56)

Title	Measurements
	OG002

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
OG002 OG003		ANCOVA		<0.0001	The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.					2-Sided							No	Superiority or Other

Secondary

Change in Mean Serum Ferritin From Baseline to Week 52

Full Analysis Population (LOCF)

Posted

Mean

Standard Deviation

ng/mL

52 weeks

ID	Title	Description
OG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
OG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Secondary

Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)

Full Analysis Population (LOCF)

Posted

Mean

Standard Deviation

% Saturation

52 weeks

ID	Title	Description
OG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
OG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Secondary

IV Iron Analysis

Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)

Posted

Median

Full Range

mg/day

52 weeks

ID	Title	Description
OG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
OG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Secondary

ESA Analysis

Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)

Posted

Median

Full Range

Units/Day

52 weeks

ID	Title	Description
OG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
OG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
OG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG0030 events0 affected95 at risk
Graft thrombosis	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Iron deficiency anemia	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Sepsis	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0005 events5 affected289 at risk EG0018 events8 affected149 at risk EG0020 events0 affected95 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0012 events2 affected149 at risk EG0021 events1 affected95 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0014 events4 affected149 at risk EG0020 events0 affected95 at risk EG003
Aortic stenosis	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0021 events1 affected95 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0012 events2 affected149 at risk EG0021 events1 affected95 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Chest discomfort	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Chest pain	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0008 events8 affected289 at risk EG0015 events5 affected149 at risk EG0022 events2 affected95 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0013 events3 affected149 at risk EG0021 events1 affected95 at risk EG003
Dyspnea	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypertensive crisis	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypertensive emergency	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Orthostatic hypotension	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Sudden death	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastroenteritis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0005 events5 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Ileitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Rectal hemorrhage	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0014 events4 affected149 at risk EG0020 events0 affected95 at risk EG003
Asthenia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Fluid Overload	General disorders	MedDRA (13.0)	Systematic Assessment	EG0005 events5 affected289 at risk EG0015 events5 affected149 at risk EG0020 events0 affected95 at risk EG003
Hyperkalemia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypokalemia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Pyrexia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Bacteremia	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Cellulitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Device related infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Gangrene	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Peritonitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Wound infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Syncope	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected289 at risk EG0012 events2 affected149 at risk EG0020 events0 affected95 at risk EG003
Transient ischemic attack	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 affected95 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0012 events2 affected149 at risk EG0021 events1 affected95 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0012 events2 affected149 at risk EG0021 events1 affected95 at risk EG003
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0014 events4 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0008 events8 affected289 at risk EG0014 events4 affected149 at risk EG0020 events0 affected95 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous graft	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Leg amputation	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Renal transplant	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG00013 events13 affected289 at risk EG0015 events5 affected149 at risk EG0021 events1 affected95 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0013 events3 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypertension	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0005 events5 affected289 at risk EG0015 events5 affected149 at risk EG0021 events1 affected95 at risk EG003
Hypotension	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0006 events6 affected289 at risk EG0014 events4 affected149 at risk EG0021 events1 affected95 at risk EG003
Vascular access complication	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0002 events2 affected289 at risk EG0013 events3 affected149 at risk EG0021 events1 affected95 at risk EG003
Lobar Pneumonia	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Staphylococcal Bacteraemia	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Staphylococcal Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Viral Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Abscess	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Anal Abscess	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Appendicitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous Graft Site Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Breast Abscess	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Catheter Site Cellulitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Catheter Site Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Clostridial Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Diabetic Foot Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Enterococcal Sepsis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Graft Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Localised Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Oesophageal Candidiasis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pelvic Abscess	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Postoperative Wound Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Tooth Abscess	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Atrial Thrombosis	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Diastolic Dysfunction	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Sinus Tachycardia	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Angina Unstable	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Cardiac Failure Acute	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cardiac Tamponade	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pericardial Effusion	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Ventricular Fibrillation	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastritis Erosive	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Swollen Tongue	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous Fistula	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Haematoma	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypovolaemic Shock	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Ischaemia	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Malignant Hypertension	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Necrosis Ischaemic	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Peripheral Ischaemia	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Peripheral Vascular Disorder	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Steal Syndrome	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Subclavian Artery Occlusion	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Adverse Event	General disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Device Occlusion	General disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hernia Obstructive	General disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Oedema	General disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arterial Bypass Operation	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous Fistula Operation	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Coronary Angioplasty	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Coronary Artery Bypass	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Debridement	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Pancreas Transplant	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Parathyroidectomy	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Renal And Pancreas Transplant	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Stent Placement	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Surgery	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Vascular Graft Complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous Fistula Site Complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0021 events1 affected95 at risk EG003
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Procedural Hypertension	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Vascular Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Cerebral Haemorrhage	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Aphasia	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Brain Oedema	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Brain Stem Haemorrhage	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cerebral Infarction	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Convulsion	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Ischaemic Cerebral Infarction	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Lumbar Radiculopathy	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Myoclonus	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Quadriplegia	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Depression	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Mental Status Changes	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Suicide Attempt	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Blood Glucose Decreased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Catheterisation Cardiac	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Electrocardiogram Qt Prolonged	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Heart Rate Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
International Normalised Ratio Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Troponin I Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Troponin Increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Renal Mass	Renal and urinary disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Urethral Obstruction	Renal and urinary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Endocarditis	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Gallbladder Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hepatic Cancer Metastatic	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Oesophageal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Acute Hepatic Failure	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Septic Shock	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Dizziness	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Haemorrhoids	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Penile Ulceration	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastroenteritis Viral	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Gastrointestinal Viral Infection	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Vertigo Positional	Ear and labyrinth disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Anaphylactic Reaction	Immune system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Graft Infection	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Renal Cyst Infection	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected149 at risk EG0020 events0 affected95 at risk EG003
Bronchitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
atrial flutter	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Mitral Valve Incompetence	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Metabolism And Nutrition Disorders	Surgical and medical procedures	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Loss of Consciousness	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Psychiatric Disorders	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0021 events1 affected95 at risk EG003
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Hepatobiliary Disorders	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Retinopathy Hypertensive	Eye disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnea	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG00010 events10 affected289 at risk EG00111 events11 affected149 at risk EG0020 events0 affected95 at risk EG0030 events0 affected95 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00014 events14 affected289 at risk EG0017 events7 affected149 at risk EG0020 events0 affected95 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00021 events21 affected289 at risk EG0016 events6 affected149 at risk EG0020 events0 affected95 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00072 events72 affected289 at risk EG00119 events19 affected149 at risk EG0020 events0 affected95 at risk EG003
Feces discolored	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00049 events49 affected289 at risk EG0010 events0 affected149 at risk EG0020 events0 affected95 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00038 events38 affected289 at risk EG00118 events18 affected149 at risk EG0020 events0 affected95 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00024 events24 affected289 at risk EG00118 events18 affected149 at risk EG0020 events0 affected95 at risk EG003
Chest pain	General disorders	MedDRA (13.0)	Systematic Assessment	EG00015 events15 affected289 at risk EG0016 events6 affected149 at risk EG0020 events0 affected95 at risk EG003
Edema peripheral	General disorders	MedDRA (13.0)	Systematic Assessment	EG0009 events9 affected289 at risk EG0018 events8 affected149 at risk EG0020 events0 affected95 at risk EG003
Pyrexia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0009 events9 affected289 at risk EG0017 events7 affected149 at risk EG0020 events0 affected95 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG00021 events21 affected289 at risk EG0019 events9 affected149 at risk EG0020 events0 affected95 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG00012 events12 affected289 at risk EG0018 events8 affected149 at risk EG0020 events0 affected95 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG00023 events23 affected289 at risk EG00114 events14 affected149 at risk EG0025 events5 affected95 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG00015 events15 affected289 at risk EG0015 events5 affected149 at risk EG0020 events0 affected95 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0008 events8 affected289 at risk EG0019 events9 affected149 at risk EG0020 events0 affected95 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0007 events7 affected289 at risk EG0017 events7 affected149 at risk EG0020 events0 affected95 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG00015 events15 affected289 at risk EG00114 events14 affected149 at risk EG0020 events0 affected95 at risk EG003
Dizziness	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG00014 events14 affected289 at risk EG00110 events10 affected149 at risk EG0020 events0 affected95 at risk EG003
Headache	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG00022 events22 affected289 at risk EG00111 events11 affected149 at risk EG0020 events0 affected95 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG00026 events26 affected289 at risk EG00115 events15 affected149 at risk EG0020 events0 affected95 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG00012 events12 affected289 at risk EG0017 events7 affected149 at risk EG0020 events0 affected95 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG00014 events14 affected289 at risk EG00110 events10 affected149 at risk EG0020 events0 affected95 at risk EG003
Hypotension	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG00015 events15 affected289 at risk EG00112 events12 affected149 at risk EG0020 events0 affected95 at risk EG003

ID	Term
D054559	Hyperphosphatemia
D051437	Renal Insufficiency
D007676	Kidney Failure, Chronic
D051436	Renal Insufficiency, Chronic

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
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	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description
BG000	Active Control-SAP	Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
BG001	KRX-0502 (Ferric Citrate)-SAP	Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
BG002	Placebo-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
BG003	KRX-0502 (Ferric Citrate)-EAP	Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	KRX-0502 (SAP)	Safety Assessment Period (Week 1-52)	114	289	211	289
EG001	Active Control (SAP)	Safety Assessment Period (Week 1-52)	73	149	88	149
EG002	KRX-0502 (EAP)	Efficacy Assessment Period (Week 52-56)	11	95	5	95
EG003	Placebo (EAP)	Efficacy Assessment Period (Week 52-56)	17	95	0	95

ID	Term
C025314	ferric citrate
D000069603	Sevelamer
C120662	calcium acetate