Efficacy and Safety of Etelcalcetide (AMG 416) in the Tre... | NCT01785849

NCT01785849

ID	Type	Description	Link
KAI-4169-006	Other Identifier	KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.)
2012-002805-23	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etelcalcetide	Experimental	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.	Drug: Etelcalcetide
Placebo	Placebo Comparator	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etelcalcetide	Drug	Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase	Participants who did not have any scheduled assessments during the EAP were considered non-responders.	Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase	Participants who had no scheduled assessments during the EAP were considered non-responders.	Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35211	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28097355	Background	Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
28274835

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
FG001	Etelcalcetide

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
BG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.1± 14.5 BG00158.4± 14.6 BG00257.7± 14.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000114 BG001103 BG002

Race

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Stratification Factor: Mean Screening Serum Parathyroid Hormone (PTH)

Mean screening parathyroid hormone (PTH) obtained within 2 weeks prior to randomization.

Number

participants

Title

Denominators

Categories

< 600 pg/mL

Title	Measurements
	BG00084 BG00187

Stratification Factor: Cinacalcet Use Within 8 Weeks of Randomization

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00034 BG00133 BG002

Stratification Factor: Region

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG000129 BG001132 BG002

Parathyroid Hormone (PTH)

Mean

Standard Deviation

pg/mL

Title

Denominators

Categories

Title	Measurements
	BG000819.7± 386.0 BG001848.7± 520.4 BG002

Phosphorus

Data were available for 250 subjects in each treatment group.

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0005.78± 1.60 BG0015.95± 1.59 BG002

Corrected Calcium

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0009.61± 0.60 BG0019.65± 0.66 BG002

Corrected Calcium Phosphorus Product (cCa x P)

Data were available for 249 and 250 subjects in each treatment group respectively.

Mean

Standard Deviation

mg²/dL²

Title

Denominators

Categories

Title	Measurements
	BG00055.54± 15.81 BG00157.37± 15.51

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 With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase

Participants who did not have any scheduled assessments during the EAP were considered non-responders.

The full analysis set, consisting of all randomized participants

Posted

Number

percentage of participants

Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000254 OG001254

Title

Denominators

Categories

Title	Measurements
	OG0008.3 OG00174.0

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 Cochran-Mantel-Haenszel test stratified by screening PTH category (< 600, ≥ 600 to ≤ 1000, and > 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with > 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.	Cochran-Mantel-Haenszel		<0.001		Odds Ratio (OR)	32.46			2-Sided	95	18.71	56.31					Superiority or Other

Secondary

Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase

Participants who had no scheduled assessments during the EAP were considered non-responders.

Full analysis set

Posted

Number

percentage of participants

Baseline and the efficacy assessment phase (Week 20 to Week 27)

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase

Full analysis set participants with observed data

Posted

Mean

Standard Error

percent change

Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase

Full analysis set participants with observed data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase (Week 20 to Week 27)

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase

Full analysis set participants with observed data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase (Week 20 to Week 27)

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase

Full analysis set participants with observed data

Posted

Mean

Standard Deviation

percent change

Baseline and the efficacy assessment phase (Week 20 to Week 27)

ID	Title	Description
OG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
OG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.			78	254	110	254
EG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.			68	251	194	251

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected254 at risk EG0010 affected251 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0016 affected251 at risk
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0012 affected251 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected254 at risk EG0013 affected251 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0013 affected251 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0012 affected251 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Gastrointestinal telangiectasia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Brain death	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Chills	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Death	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Device issue	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Impaired healing	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Malaise	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Medical device complication	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0012 affected251 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0013 affected251 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected254 at risk EG0010 affected251 at risk
Thrombosis in device	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Abscess limb	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Arthritis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Device related infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Diabetic foot infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Gangrene	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0012 affected251 at risk
H1N1 influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected254 at risk EG0016 affected251 at risk
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected254 at risk EG0012 affected251 at risk
Septic embolus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Septic shock	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Subacute endocarditis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0011 affected251 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Wound infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0012 affected251 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0003 affected254 at risk EG0010 affected251 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0011 affected251 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected254 at risk EG0014 affected251 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0014 affected251 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0012 affected251 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Biliary cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Bone giant cell tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0011 affected251 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Anxiety	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Confusional state	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Delirium	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Mental status changes	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Urinary retention	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Accelerated hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Haematoma	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0010 affected251 at risk
Hypertensive emergency	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0012 affected251 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected254 at risk EG0011 affected251 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0011 affected251 at risk
Shock	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk
Vascular rupture	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Vascular stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG0010 affected251 at risk
Venous stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected254 at risk EG0011 affected251 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00017 affected254 at risk EG00118 affected251 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected254 at risk EG00131 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00018 affected254 at risk EG00125 affected251 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00013 affected254 at risk EG00111 affected251 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG00014 affected254 at risk EG00111 affected251 at risk
Blood calcium decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00021 affected254 at risk EG001153 affected251 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected254 at risk EG00118 affected251 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00018 affected254 at risk EG00130 affected251 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00011 affected254 at risk EG00117 affected251 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00020 affected254 at risk EG00118 affected251 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected254 at risk EG00113 affected251 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00016 affected254 at risk EG00112 affected251 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected254 at risk EG00114 affected251 at risk

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
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
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance

ID	Term
D006962	Hyperparathyroidism, Secondary
D051436	Renal Insufficiency, Chronic
D006996	Hypocalcemia