Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet | NCT01896232

ID	Type	Description	Link
2013-000192-33	EudraCT Number

Label	Type	Description	Intervention Names
Cinacalcet	Active Comparator	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Drug: Cinacalcet Drug: Intravenous Placebo
Etelcalcetide	Experimental	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Drug: Etelcalcetide Drug: Oral Placebo

Name	Type	Description	Arm Group Labels	Other Names
Etelcalcetide	Drug	Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.	Etelcalcetide

Measure	Description	Time Frame
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis		Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Measure	Description	Time Frame
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase		Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Azusa	California	91702	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
28097356	Background	Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.
29392552

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.

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% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis

Full analysis set participants with PTH data during the EAP

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Units	Counts
Participants	OG000310 OG001298

Title

Denominators

Categories

Title	Measurements
	OG00063.9 OG00177.9

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	The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP. The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region.					Stratified Treatment Difference	-10.48			2-Sided	95	-17.45	-3.51					Non-Inferiority or Equivalence	Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was < 12%, the prespecified margin for non-inferiority.

Secondary

Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).

Posted

Number

percentage of participants

Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Units

Secondary

Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Units

Secondary

Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks

Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.

Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Posted

Least Squares Mean

Standard Error

days of vomiting or nausea per week

First 8 weeks

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Secondary

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

Full analysis set with available data.

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase (weeks 20 - 27)

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Units	Counts
Participants

Secondary

Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase

Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.

Posted

Number

percentage of participants

Efficacy assessment phase (weeks 20 - 27)

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Units	Counts

Secondary

Mean Severity of Nausea in the First 8 Weeks

Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.

Full analysis set with available data

Posted

Least Squares Mean

Standard Error

units on a scale

First 8 weeks

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Secondary

Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks

The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.

For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Posted

Least Squares Mean

Standard Error

vomiting episodes per week

First 8 weeks

ID	Title	Description
OG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
OG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected341 at risk EG0010 affected338 at risk
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0011 affected338 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Angina unstable	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0012 affected338 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Mitral valve disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Hypothyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Glaucoma	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Ascites	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Ileus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Device malfunction	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Device occlusion	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Impaired healing	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Medical device complication	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Sudden death	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Abdominal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Appendicitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Arteriovenous graft site abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Bacterial infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Bacterial sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0010 affected338 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0010 affected338 at risk
Cholecystitis infective	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Device related infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0011 affected338 at risk
Device related sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Diabetic foot infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Erysipelas	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Gangrene	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0014 affected338 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Infected fistula	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Liver abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Peritonitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pharyngolaryngeal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Postoperative wound infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pyelonephritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Renal cyst infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected341 at risk EG0013 affected338 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Wound infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0012 affected338 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0010 affected338 at risk
Haemodialysis complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Kidney rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0010 affected338 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected341 at risk EG0010 affected338 at risk
Vascular injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Blood calcium decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Colonoscopy	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Hepatic enzyme increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
International normalised ratio increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Diabetes with hyperosmolarity	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected341 at risk EG0011 affected338 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Brown tumour	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Amputation stump pain	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Aphasia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Coma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Hemiparesis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Lacunar infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Neurological symptom	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Optic neuritis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Polyneuropathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Somnolence	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Confusional state	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Depression suicidal	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Sopor	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Arterial thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0010 affected338 at risk
Extremity necrosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0011 affected338 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Hypertensive crisis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0010 affected338 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0012 affected338 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected341 at risk EG0012 affected338 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected341 at risk EG0011 affected338 at risk
Venous stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected341 at risk EG0011 affected338 at risk

ID	Term
D006962	Hyperparathyroidism, Secondary
D051436	Renal Insufficiency, Chronic

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

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
BG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cinacalcet	Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.			93	341	259	341
EG001	Etelcalcetide	Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.			85	338	278	338