Pediatric Chronic Kidney Disease Safety and Efficacy | NCT01277510

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.	Drug: placebo Drug: Standard of Care
Cinacalcet	Experimental	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.	Drug: cinacalcet capsule Drug: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
cinacalcet capsule	Drug	Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.	Cinacalcet

Measure	Description	Time Frame
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.	From Baseline to the Efficacy Assessment Phase, Weeks 25-30

Measure	Description	Time Frame
Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase	The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35233	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
30506144	Background	Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30.
32367309

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

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

Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.

Posted

Number

percentage of participants

From Baseline to the Efficacy Assessment Phase, Weeks 25-30

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Units	Counts
Participants	OG00021 OG00122

Title

Denominators

Categories

Title	Measurements
	OG00019.0 OG00154.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.	Cochran-Mantel-Haenszel	Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).	0.017		Difference (Cinacalcet - Placebo)	35.50			2-Sided	95	8.76	62.24					Superiority or Other (legacy)

Secondary

Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Full analysis set

Posted

Number

pecentage of participants

From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period

Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."

Full analysis set

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase

Full analysis set; data for one participant in the Placebo group were not available.

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase

Full analysis set

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Growth Velocity From Baseline to End of Double-blind Phase

Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.

Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.

Posted

Least Squares Mean

95% Confidence Interval

cm/year

From Baseline to end of Efficacy Assessment at Week 30

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Growth Velocity From End of Double-blind Phase to End of Open-label Phase

Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.

Full analysis set. Only participants with available data were included in the anaysis.

Posted

Mean

Standard Deviation

cm/year

End of double-blind phase (Week 30) until end of the open-label phase (Week 60)

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Secondary

Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase

Full analysis set; only participants with available data were included in the analysis.

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

ID	Title	Description
OG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
OG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG0030 affected4 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Papilloedema	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Medical device complication	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Thirst	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Thrombosis in device	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Rubber sensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Transplant rejection	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Device related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Measles	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Peritonitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Graft complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Blood pressure increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Haemoglobin increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Weight decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0021 affected6 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Migraine	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0012 affected22 at risk EG0021 affected6 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG0030 affected4 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Keratitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0013 affected22 at risk EG0022 affected6 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0014 affected22 at risk EG0022 affected6 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected21 at risk EG0017 affected22 at risk EG0021 affected6 at risk EG003
Catheter site pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Catheter site pruritus	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Catheter site related reaction	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Chills	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0011 affected22 at risk EG0021 affected6 at risk EG003
Device breakage	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Device leakage	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Face oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Feeling cold	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Local swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0011 affected22 at risk EG0022 affected6 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Catheter site infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Device related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0013 affected22 at risk EG0021 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Oral herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Peritonitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Viral infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Dialysis related complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Blood calcium abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Blood phosphorus increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Haematocrit decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Haemoglobin increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected21 at risk EG0015 affected22 at risk EG0022 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0013 affected22 at risk EG0020 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0013 affected22 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0021 affected6 at risk EG003
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0013 affected22 at risk EG0021 affected6 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0021 affected6 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Tremor	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0013 affected22 at risk EG0020 affected6 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003
Daydreaming	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Staring	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected21 at risk EG0011 affected22 at risk EG0021 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Dandruff	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected22 at risk EG0021 affected6 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Haematoma	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected22 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected21 at risk EG0011 affected22 at risk EG0020 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected22 at risk EG0020 affected6 at risk EG003

ID	Term
D051436	Renal Insufficiency, Chronic
D006961	Hyperparathyroidism
D006962	Hyperparathyroidism, Secondary
D007674	Kidney Diseases

ID	Term
D051437	Renal Insufficiency
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
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Placebo	Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
BG001	Cinacalcet	Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
BG002	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind Phase: Placebo	9	21	17	21
EG001	Double-blind Phase: Cinacalcet	9	22	16	22
EG002	Open-label Phase: Previous Placebo	3	6	6	6
EG003	Open-label Phase: Previous Cinacalcet	1	4	3	4