Efficacy and Safety of Etelcalcetide (AMG 416) in the Tre... | NCT01788046

NCT01788046

ID	Type	Description	Link
KAI-4169-007	Other Identifier	KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.)
2012-002806-31	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
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
Etelcalcetide	Experimental	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.	Drug: Etelcalcetide

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 weeks 5, 9, 13, and 17 (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 > 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		Mobile	Alabama	36608	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.
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
	BG00059.0± 13.9 BG00158.4± 14.6 BG00258.7± 14.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095 BG00193 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic/Latino

Title	Measurements
	BG00033 BG00132 BG002

Stratification Factor: Screening Serum Parathroid Hormone

Number

participants

Title

Denominators

Categories

< 600 pg/mL

Title	Measurements
	BG00084 BG00184 BG002

Stratification Factor: Cinacalcet Use Within 8 Weeks of Randomization

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00033 BG00129 BG002

Stratification Factor: Region

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG000150 BG001146 BG002

Parathyroid Hormone

Mean

Standard Deviation

pg/mL

Title

Denominators

Categories

Title	Measurements
	BG000851.7± 552.0 BG001845.0± 464.3 BG002

Phosphorus

Data available for 257 and 251 participants in each treatment group respectively

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0005.83± 1.45 BG0015.76± 1.60

Corrected Calcium (cCa)

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0009.70± 0.69 BG0019.63± 0.65 BG002

Corrected Calcium Phosphorus Product (cCa x P)

Data available for 257 and 251 participants in each treatment group respectively

Mean

Standard Deviation

mg²/dL²

Title

Denominators

Categories

Title	Measurements
	BG00056.37± 14.50 BG00155.30± 15.27

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 > 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.

Units	Counts
Participants	OG000260 OG001255

Title

Denominators

Categories

Title	Measurements
	OG0009.6 OG00175.3

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 percentage of participants with > 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.	Cochran-Mantel-Haenszel		< 0.001		Odds Ratio (OR)	30.80			2-Sided	95	18.18	52.17					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.

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.

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.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) 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.

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 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.

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.			71	259	132	259
EG001	Etelcalcetide	Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.			62	252	199	252

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected259 at risk EG0013 affected252 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0011 affected252 at risk
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Arrhythmia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0012 affected252 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Bundle branch block right	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected259 at risk EG0012 affected252 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Primary hyperaldosteronism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0012 affected252 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Asthenia	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Catheter site haematoma	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Hernia obstructive	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Medical device complication	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0011 affected252 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0013 affected252 at risk
Sudden death	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Surgical failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Abdominal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Abscess limb	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Bacterial sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Burn infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0012 affected252 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Clostridium difficile sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Device related sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Diabetic foot infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Gangrene	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected259 at risk EG0011 affected252 at risk
Herpes zoster meningoencephalitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Intervertebral discitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Meningitis aseptic	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected259 at risk EG0010 affected252 at risk
Periodontitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00010 affected259 at risk EG0014 affected252 at risk
Postoperative abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Prostatic abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0012 affected252 at risk
Sepsis syndrome	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Skin graft infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Viral infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Viral myocarditis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Skin graft failure	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0012 affected252 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0004 affected259 at risk EG0012 affected252 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hepatic enzyme increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0016 affected252 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0012 affected252 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Balance disorder	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Brain injury	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0011 affected252 at risk
Dementia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hyperglycaemic seizure	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Tremor	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0010 affected252 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Confusional state	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Mental status changes	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Urinary retention	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected259 at risk EG0010 affected252 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected259 at risk EG0012 affected252 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected259 at risk EG0012 affected252 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0012 affected252 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Diabetic neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Palpable purpura	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0011 affected252 at risk
Finger amputation	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Accelerated hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Hypertensive crisis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Malignant hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Poor peripheral circulation	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Thrombophlebitis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected259 at risk EG0010 affected252 at risk
Venous stenosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG0011 affected252 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG00013 affected259 at risk EG0018 affected252 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00025 affected259 at risk EG00135 affected252 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00018 affected259 at risk EG00123 affected252 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected259 at risk EG00119 affected252 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00015 affected259 at risk EG00113 affected252 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG00012 affected259 at risk EG00116 affected252 at risk
Blood calcium decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00031 affected259 at risk EG001168 affected252 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected259 at risk EG00117 affected252 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected259 at risk EG00111 affected252 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected259 at risk EG00114 affected252 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00016 affected259 at risk EG00128 affected252 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00011 affected259 at risk EG00120 affected252 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected259 at risk EG00110 affected252 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00012 affected259 at risk EG00118 affected252 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected259 at risk EG00114 affected252 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