ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitam... | NCT00379899

Label	Type	Description	Intervention Names
Control	Active Comparator	Standard of care, without use of cinacalcet.	Drug: cinacalcet

Name	Type	Description	Arm Group Labels	Other Names
cinacalcet	Drug	Low dose vitamin D with cinacalcet	Control	cinacalcet + low dose vitamin D

Measure	Description	Time Frame
Percent Change From Baseline in CAC Score	Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.	Baseline and Week 52

Measure	Description	Time Frame
Number of Participants Achieving > 15% Progression of CAC.	Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52	52 weeks
Absolute Change in PTH

Name	Affiliation	Role
MD	Amgen	Study Director

PubMed Identifier	Type	Citation	Retractions
24151766	Background	Bellasi A, Reiner M, Petavy F, Goodman W, Floege J, Raggi P. Presence of valvular calcification predicts the response to cinacalcet: data from the ADVANCE study. J Heart Valve Dis. 2013 May;22(3):391-9.
22313328	Background	Boer R, Lalla AM, Belozeroff V. Cost-effectiveness of cinacalcet in secondary hyperparathyroidism in the United States. J Med Econ. 2012;15(3):509-20. doi: 10.3111/13696998.2012.664799. Epub 2012 Feb 21.

Label	URL
FDA-approved Drug Labeling	View source

ID	Title	Description
FG000	Cinacalcet	Cinacalcet plus low dose vitamin D
FG001	Control	Flexible vitamin D dosing

ID	Title	Description
BG000	Cinacalcet	Cinacalcet plus low dose vitamin D
BG001	Control	Flexible vitamin D dosing
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000180 BG001180 BG002360

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

Percent Change From Baseline in CAC Score

Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Units on a scale

Baseline and Week 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000115 OG001120

Title

Denominators

Categories

Title	Measurements
	OG00043.74± 7.40 OG00157.39± 7.77

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		Cochran-Mantel-Haenszel	Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)	0.073													No	Superiority or Other

Secondary

Number of Participants Achieving > 15% Progression of CAC.

Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Number

Participants

52 weeks

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Absolute Change in PTH

Absolute change from baseline in intact Parathyroid Hormone (iPTH)

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

pg/mL

Baseline and Week 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Change From Baseline in AC Score

Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Units on a scale

Baseline and Week 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Change From Baseline of the Progression of AVC.

Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Units on a scale

Baseline and Week 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Percent Change in PTH

Percent change from baseline in intact Parathyroid Hormone (iPTH)

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Percentage

Baseline and Week 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Absolute Change in Calcium

Absolute change from baseline in serum calcium to weeks 44 through 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

mg/dL

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Percent Change in Calcium

Percent change from baseline in corrected serum calcium to weeks 44 through 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Percentage

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Absolute Change in Phosphorus

Absolute change from baseline in serum phosphorus to weeks 44 through 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

mg/dL

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Percent Change in Phosphorus

Percent change from baseline in serum phosphorus to weeks 44 through 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Percentage

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Absolute Change in Ca x P

Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

(mg/dL)2

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Secondary

Percent Change in Ca x P

Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52

Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score

Posted

Mean

Standard Error

Percentage

Baseline and Weeks 44 through 52

ID	Title	Description
OG000	Cinacalcet	Cinacalcet plus low dose vitamin D
OG001	Control	Flexible vitamin D dosing

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected180 at risk EG0013 affected180 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hypoprothrombinaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected180 at risk EG0013 affected180 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected180 at risk EG0014 affected180 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0013 affected180 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected180 at risk EG0012 affected180 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0011 affected180 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0012 affected180 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Familial mediterranean fever	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Diabetic retinopathy	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Eye pain	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0012 affected180 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Anal polyp	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0013 affected180 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0012 affected180 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Haemorrhagic ascites	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Melaena	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected180 at risk EG0010 affected180 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0012 affected180 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Catheter related complication	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Catheter thrombosis	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Chills	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Drug intolerance	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Multi-organ failure	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected180 at risk EG0014 affected180 at risk
Sudden cardiac death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Biliary cyst	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Jaundice	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Transplant rejection	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Abdominal abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Abscess limb	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Abscess neck	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0010 affected180 at risk
Bacterial infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Bacterial sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Bone abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Bronchiectasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Catheter related infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Catheter sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0011 affected180 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Central line infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Diverticulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Endocarditis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Enterocolitis viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Erysipelas	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Gangrene	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Graft infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hepatitis C	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Lobar pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Localised infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Osteomyelitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Peritoneal candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0017 affected180 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Postoperative wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Scrotal abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0005 affected180 at risk EG0014 affected180 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Staphylococcal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Urosepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Viral infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0006 affected180 at risk EG0013 affected180 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0011 affected180 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Blood glucose increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Haemoglobin decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected180 at risk EG0012 affected180 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected180 at risk EG0013 affected180 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected180 at risk EG0010 affected180 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Convulsion	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Dementia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Disturbance in attention	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Encephalopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Epilepsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hypertonia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Myoclonus	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Spinal cord compression	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0012 affected180 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Mental status changes	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0013 affected180 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0011 affected180 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected180 at risk EG0012 affected180 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected180 at risk EG0014 affected180 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0011 affected180 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0015 affected180 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Arteriovenous graft	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Renal transplant	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Aortic aneurysm	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Embolism	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Extremity necrosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected180 at risk EG0016 affected180 at risk
Hypertensive crisis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0012 affected180 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0013 affected180 at risk
Labile blood pressure	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Malignant hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected180 at risk EG0010 affected180 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected180 at risk EG0010 affected180 at risk
Shock	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Venous stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cinacalcet				88	180	95	180
EG001	Control Group				82	180	93	180

ID	Term
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic
D061205	Vascular Calcification
D002114	Calcinosis
D002318	Cardiovascular Diseases
D006961	Hyperparathyroidism
D007674	Kidney Diseases
D006962	Hyperparathyroidism, Secondary

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
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
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
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds