Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dia... | NCT01503021

Label	Type	Description	Intervention Names
SFP/Placebo	Other	Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks	Drug: SFP Other: Placebo
Placebo/SFP	Other	Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.	Drug: SFP Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SFP	Drug	Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate	Placebo/SFP SFP/Placebo

Measure	Description	Time Frame
Incidence of Treatment-emergent Adverse Events	Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.	Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension	Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.	Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Related Suspected Hypersensitivity Reactions	Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.	Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

Measure	Description	Time Frame
Incidence of Composite Cardiovascular Events	Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.	Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

Measure	Description	Time Frame
Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2	Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.	Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

Name	Affiliation	Role
Ray Pratt, MD	Rockwell Medical, Inc	Study Director

ID	Title	Description
FG000	SFP/Placebo	Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
FG001	Placebo/SFP

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

Incidence of Treatment-emergent Adverse Events

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Units	Counts
Participants	OG000693 OG001687 OG002309

Title

Denominators

Categories

Title	Measurements
	OG00031.6 OG00135.1 OG00295.1

Primary

Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Primary

Incidence of Related Suspected Hypersensitivity Reactions

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Secondary

Incidence of Composite Cardiovascular Events

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Secondary

Incidence of Hemodialysis Vascular Access Thrombotic Events

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Secondary

Incidence of Other Thrombotic Events

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Secondary

Incidence of Systemic/Serious Infections

Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Secondary

Incidence of Serious Adverse Events

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

percentage of participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Other Pre-specified

Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2

Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micromoles per liter

Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5

Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micromoles per liter

Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2

Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micromoles per liter

Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5

Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micromoles per liter

Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2

Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

percent transferrin saturation

Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5

Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

percent transferrin saturation

Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study

ID	Title	Description
OG000	SFP/Placebo	Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron
OG001	Placebo/SFP	Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks. SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Other Pre-specified

Ferritin

The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micrograms per liter

Baseline, up to 53 weeks for Extension Study

ID	Title	Description
OG000	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Units	Counts
Participants	OG000

Other Pre-specified

Serum Iron

The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

micromoles per liter

Baseline, up to 53 weeks for Extension Study

ID	Title	Description
OG000	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Units	Counts
Participants	OG000

Other Pre-specified

Transferrin Saturation

The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Mean

Standard Deviation

percent transferrin saturation

Baseline, up to 53 weeks for Extension Study

ID	Title	Description
OG000	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Patients Meeting Hy's Law Criteria

The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.

All participants who received at least one dose of study drug (SFP or placebo, as applicable).

Posted

Number

participants

Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study

ID	Title	Description
OG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
OG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate
OG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0025 affected309 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected693 at risk EG0011 affected687 at risk EG0025 affected309 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0025 affected309 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0024 affected309 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0024 affected309 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0012 affected687 at risk EG0026 affected309 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0012 affected687 at risk EG0025 affected309 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0013 affected687 at risk EG0021 affected309 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0022 affected309 at risk
Gait disturbance	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0024 affected309 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0012 affected687 at risk EG0026 affected309 at risk
Cholecystitis infective	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0011 affected687 at risk EG0022 affected309 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0015 affected687 at risk EG0027 affected309 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Viral infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0011 affected687 at risk EG0025 affected309 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0012 affected687 at risk EG0022 affected309 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0011 affected687 at risk EG0027 affected309 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected693 at risk EG0011 affected687 at risk EG0027 affected309 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0023 affected309 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected693 at risk EG0011 affected687 at risk EG0025 affected309 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0020 affected309 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0012 affected687 at risk EG0023 affected309 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0020 affected309 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0023 affected309 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected693 at risk EG0011 affected687 at risk EG0024 affected309 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0021 affected309 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0011 affected687 at risk EG0024 affected309 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Angina unstable	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0028 affected309 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0024 affected309 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Medical device complication	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Adverse drug reaction	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Device pacing issue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Malaise	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Sudden death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hepatic necrosis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0026 affected309 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0025 affected309 at risk
Gangrene	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0024 affected309 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0024 affected309 at risk
Diabetic foot infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Abscess limb	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Chest wall abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Nasal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Pharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Wound sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Areriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0029 affected309 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0023 affected309 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Vascular dementia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0024 affected309 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0022 affected309 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Peripheral embolism	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Steal syndrome	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Venous occlusion	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
Retinal artery embolism	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk
International normalised ratio increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected693 at risk EG0010 affected687 at risk EG0021 affected309 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36688	United States

ID	Title	Description
BG000	SFP/Placebo	Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
BG001	Placebo/SFP	Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
BG002	Total	Total of all reporting groups

ID	Term
D007676	Kidney Failure, Chronic
D051436	Renal Insufficiency, Chronic

ID	Term
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	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Soluble Ferric Pyrophosphate	Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.	30	693	123	693
EG001	Placebo	Parent Study: Blinded standard liquid bicarbonate concentrate	35	687	131	687
EG002	Open-label Soluble Ferric Pyrophosphate	Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.	144	309	253	309