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Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

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ClinicalTrials.gov Identifier: NCT01785875
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperparathyroidism, Secondary
Intervention Drug: Etelcalcetide
Enrollment 891
Recruitment Details

This single-arm study was conducted at 205 centers in the US, Canada, Europe, Israel, Russian Federation and Australia. Participants were enrolled from 31 July 2013 to 9 June 2014.

Participants who rolled over into another single-arm extension study 20130213 (NCT02102204) are reported as discontinuing the study due to protocol specified criteria.

Pre-assignment Details This extension study enrolled participants from 1 of 3 parent studies: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970). In Studies 20120229 and 20120230, patients received either placebo or etelcalcetide 3 times a week (TIW) for up to 26 weeks; In Study 20120359, patients received 5 mg etelcalcetide TIW for 4 weeks.
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide
Hide Arm/Group Description Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Period Title: Overall Study
Started 384 384 123
Received Etelcalcetide 383 384 123
Completed 90 [1] 95 [1] 16 [1]
Not Completed 294 289 107
Reason Not Completed
Withdrawal by Subject             41             34             36
Lost to Follow-up             19             22             6
Death             27             16             7
Sponsor Decision             0             2             0
Protocol Specified Criteria             207             214             55
Missing             0             1             3
[1]
Completed etelcalcetide and the 30-day safety follow-up period
Arm/Group Title Etelcalcetide
Hide Arm/Group Description All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Baseline Participants 891
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 891 participants
58.3  (14.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 891 participants
< 65 years 577
≥ 65 years 314
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 891 participants
Female
341
  38.3%
Male
550
  61.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 891 participants
American Indian or Alaska Native 1
Asian 29
Black (or African American) 270
Native Hawaiian or Other Pacific Islander 12
White 567
Other 12
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 891 participants
Hispanic/Latino 122
Not Hispanic/Latino 769
Parathyroid Hormone (PTH) Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 891 participants
< 600 pg/mL 405
600 - ≤ 1000 pg/mL 221
> 1000 pg/mL 228
Missing 37
PTH Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 891 participants
769.5  (574.4)
[1]
Measure Description: Data available for 854 participants
Corrected Calcium   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 891 participants
9.67  (0.68)
[1]
Measure Description: Data available for 889 participants
Phosphorus   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 891 participants
5.63  (1.75)
[1]
Measure Description: Data available for 887 participants
Corrected Calcium Phosphorus Product (cCa x P)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg²/dL²
Number Analyzed 891 participants
54.36  (17.17)
[1]
Measure Description: Data available for 887 participants
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
Time Frame From first dose until 30 days after last dose; the treatment period was 52 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of etelcalcetide.
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 383 384 123 890
Measure Type: Number
Unit of Measure: participants
Any adverse event 354 337 108 799
Serious adverse events 161 142 53 356
Treatment-related adverse events 215 141 36 392
Treatment-related serious adverse events 6 5 2 13
AEs leading to discontinuation of etelcalcetide 22 11 8 41
Fatal adverse events 27 16 8 51
2.Primary Outcome
Title Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Hide Description Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of etelcalcetide.
Arm/Group Title Etelcalcetide Total
Hide Arm/Group Description:
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 890
Measure Type: Number
Unit of Measure: participants
Alanine aminotransferase increase 1
Albumin decrease 9
Alkaline phosphatase increase 2
Aspartate aminotransferase increase 3
Bilirubin increase 1
Calcium (corrected) decrease 51
Calcium (corrected) increase 8
Phosphorus decrease 77
Potassium decrease 9
Potassium increase 69
Hemoglobin decrease 4
Hemoglobin increase 1
3.Primary Outcome
Title Number of Participants Who Developed Anti-etelcalcetide Antibodies
Hide Description A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Time Frame Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 369 384 123 876
Measure Type: Number
Unit of Measure: participants
10 15 2 27
4.Primary Outcome
Title Change From Baseline in Blood Pressure
Hide Description Blood pressure (BP) values were taken post-hemodialysis assessments.
Time Frame Baseline and Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 383 384 123 890
Mean (Standard Error)
Unit of Measure: mmHg
Systolic BP Week 24 (n = 329, 342, 104, 775) 4.0  (1.5) 4.5  (1.4) -5.5  (2.8) 2.9  (1.0)
Systolic BP Week 48 (n = 305, 317, 74, 696) 3.5  (1.6) 6.5  (1.5) -6.8  (3.0) 3.8  (1.0)
Diastolic BP Week 24 (n = 329, 343, 104, 776) 2.2  (0.8) 1.2  (0.9) -5.1  (1.5) 0.8  (0.6)
Diastolic BP Week 48 (n = 305, 317, 74, 696) 1.1  (0.9) 0.8  (0.9) -2.6  (1.7) 0.6  (0.6)
5.Secondary Outcome
Title Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
Hide Description The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
Time Frame Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 341 332 106 779
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.2
(76.7 to 85.2)
54.5
(49.0 to 60.0)
65.1
(55.2 to 74.1)
67.7
(64.2 to 70.9)
6.Secondary Outcome
Title Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
Hide Description The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
Time Frame Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with pre-dialysis PTH assessment at baseline and during EAP12
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 302 300 74 676
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.5
(77.7 to 86.6)
53.3
(47.5 to 59.1)
63.5
(51.5 to 74.4)
67.5
(63.8 to 71.0)
7.Secondary Outcome
Title Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 352 355 108 815
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.7
(50.3 to 60.9)
59.7
(54.4 to 64.9)
54.6
(44.8 to 64.2)
57.3
(53.8 to 60.7)
8.Secondary Outcome
Title Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Hide Description [Not Specified]
Time Frame Week 46 to 53
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with predialysis PTH assessment during the EAP12
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 312 321 75 708
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.8
(49.1 to 60.4)
61.1
(55.5 to 66.4)
42.7
(31.3 to 54.6)
56.4
(52.6 to 60.0)
9.Secondary Outcome
Title Percent Change From Baseline in Mean PTH During the EAP
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 341 332 106 779
Mean (Standard Error)
Unit of Measure: percent change
-54.55  (2.12) 3.92  (8.68) -28.40  (6.96) -26.07  (4.04)
10.Secondary Outcome
Title Percent Change From Baseline in Mean PTH During the EAP12
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 302 300 74 676
Mean (Standard Error)
Unit of Measure: percent change
-55.41  (2.20) 4.78  (9.62) -27.05  (7.57) -25.59  (4.59)
11.Secondary Outcome
Title Percent Change From Baseline in Mean Corrected Calcium During the EAP
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 352 352 103 807
Mean (Standard Error)
Unit of Measure: percent change
-10.01  (0.52) -6.74  (0.47) -8.65  (1.04) -8.41  (0.34)
12.Secondary Outcome
Title Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 310 319 75 704
Mean (Standard Error)
Unit of Measure: percent change
-9.76  (0.52) -6.43  (0.45) -9.73  (1.14) -8.25  (0.34)
13.Secondary Outcome
Title Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 342 345 99 786
Mean (Standard Error)
Unit of Measure: percent change
-15.26  (1.58) -10.41  (1.61) -6.58  (4.28) -12.04  (1.13)
14.Secondary Outcome
Title Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 309 317 75 701
Mean (Standard Error)
Unit of Measure: percent change
-15.30  (1.53) -9.78  (1.62) -7.29  (4.82) -11.95  (1.13)
15.Secondary Outcome
Title Percent Change From Baseline in Mean Phosphorus During the EAP
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 343 348 105 796
Mean (Standard Error)
Unit of Measure: percent change
-5.71  (1.71) -3.50  (1.68) 2.82  (4.56) -3.62  (1.20)
16.Secondary Outcome
Title Percent Change From Baseline in Mean Phosphorus During the EAP12
Hide Description [Not Specified]
Time Frame Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Etelcalcetide Total
Hide Arm/Group Description:
Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Number of Participants Analyzed 309 319 75 703
Mean (Standard Error)
Unit of Measure: percent change
-5.87  (1.65) -3.06  (1.73) 3.53  (5.46) -3.59  (1.22)
Time Frame From first dose until 30 days after last dose; the treatment period was 52 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title 20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Total
Hide Arm/Group Description Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
All-Cause Mortality
20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   161/383 (42.04%)   142/384 (36.98%)   53/123 (43.09%)   356/890 (40.00%) 
Blood and lymphatic system disorders         
Anaemia  1  3/383 (0.78%)  1/384 (0.26%)  2/123 (1.63%)  6/890 (0.67%) 
Anaemia of chronic disease  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Haemorrhagic anaemia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Leukocytosis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Lymphadenopathy  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Nephrogenic anaemia  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Thrombocytopenia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cardiac disorders         
Acute coronary syndrome  1  3/383 (0.78%)  0/384 (0.00%)  1/123 (0.81%)  4/890 (0.45%) 
Acute myocardial infarction  1  5/383 (1.31%)  6/384 (1.56%)  0/123 (0.00%)  11/890 (1.24%) 
Angina pectoris  1  2/383 (0.52%)  3/384 (0.78%)  2/123 (1.63%)  7/890 (0.79%) 
Angina unstable  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Aortic valve disease  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Aortic valve incompetence  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Aortic valve stenosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Arrhythmia  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Atrial fibrillation  1  9/383 (2.35%)  4/384 (1.04%)  0/123 (0.00%)  13/890 (1.46%) 
Atrial flutter  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Atrioventricular block complete  1  1/383 (0.26%)  1/384 (0.26%)  1/123 (0.81%)  3/890 (0.34%) 
Bradycardia  1  2/383 (0.52%)  2/384 (0.52%)  1/123 (0.81%)  5/890 (0.56%) 
Cardiac arrest  1  6/383 (1.57%)  2/384 (0.52%)  4/123 (3.25%)  12/890 (1.35%) 
Cardiac disorder  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cardiac failure  1  2/383 (0.52%)  3/384 (0.78%)  0/123 (0.00%)  5/890 (0.56%) 
Cardiac failure acute  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Cardiac failure chronic  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cardiac failure congestive  1  8/383 (2.09%)  7/384 (1.82%)  3/123 (2.44%)  18/890 (2.02%) 
Cardiac valve disease  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cardio-respiratory arrest  1  1/383 (0.26%)  3/384 (0.78%)  0/123 (0.00%)  4/890 (0.45%) 
Cardiogenic shock  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Cardiomyopathy  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cardiovascular insufficiency  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Coronary artery disease  1  3/383 (0.78%)  6/384 (1.56%)  0/123 (0.00%)  9/890 (1.01%) 
Coronary artery stenosis  1  3/383 (0.78%)  0/384 (0.00%)  0/123 (0.00%)  3/890 (0.34%) 
Mitral valve incompetence  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Myocardial infarction  1  2/383 (0.52%)  4/384 (1.04%)  1/123 (0.81%)  7/890 (0.79%) 
Myocardial ischaemia  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Palpitations  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pericardial effusion  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Sinus node dysfunction  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Supraventricular tachycardia  1  1/383 (0.26%)  2/384 (0.52%)  0/123 (0.00%)  3/890 (0.34%) 
Tachycardia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Torsade de pointes  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Tricuspid valve incompetence  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Ventricular fibrillation  1  2/383 (0.52%)  2/384 (0.52%)  2/123 (1.63%)  6/890 (0.67%) 
Ear and labyrinth disorders         
Deafness neurosensory  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Vertigo  1  2/383 (0.52%)  1/384 (0.26%)  0/123 (0.00%)  3/890 (0.34%) 
Endocrine disorders         
Goitre  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Eye disorders         
Cataract  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Diplopia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Lens dislocation  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Optic neuropathy  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Gastrointestinal disorders         
Abdominal adhesions  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Abdominal pain  1  3/383 (0.78%)  3/384 (0.78%)  1/123 (0.81%)  7/890 (0.79%) 
Abdominal pain lower  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Abdominal pain upper  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Abdominal wall haematoma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Anorectal varices haemorrhage  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Ascites  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Colitis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Colitis ischaemic  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Constipation  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Dental caries  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Diabetic gastroparesis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Diarrhoea  1  2/383 (0.52%)  2/384 (0.52%)  0/123 (0.00%)  4/890 (0.45%) 
Diverticular perforation  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Diverticulum intestinal  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Duodenal ulcer  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Enteritis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Enterocutaneous fistula  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Gastric antral vascular ectasia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Gastric disorder  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Gastric haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Gastritis  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Gastritis erosive  1  1/383 (0.26%)  2/384 (0.52%)  0/123 (0.00%)  3/890 (0.34%) 
Gastritis haemorrhagic  1  1/383 (0.26%)  0/384 (0.00%)  2/123 (1.63%)  3/890 (0.34%) 
Gastrointestinal haemorrhage  1  2/383 (0.52%)  4/384 (1.04%)  4/123 (3.25%)  10/890 (1.12%) 
Gastrointestinal necrosis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Gastrointestinal vascular malformation  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Gastrooesophageal reflux disease  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haematemesis  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Haemorrhoidal haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Haemorrhoids  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Ileus  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Inguinal hernia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Intestinal ischaemia  1  3/383 (0.78%)  0/384 (0.00%)  0/123 (0.00%)  3/890 (0.34%) 
Intestinal perforation  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Large intestine perforation  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Large intestine polyp  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Megacolon  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Nausea  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Oesophagitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pancreatic duct obstruction  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pancreatitis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Pancreatitis acute  1  2/383 (0.52%)  1/384 (0.26%)  0/123 (0.00%)  3/890 (0.34%) 
Rectal haemorrhage  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Small intestinal obstruction  1  1/383 (0.26%)  2/384 (0.52%)  1/123 (0.81%)  4/890 (0.45%) 
Subileus  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Upper gastrointestinal haemorrhage  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Vomiting  1  3/383 (0.78%)  1/384 (0.26%)  1/123 (0.81%)  5/890 (0.56%) 
General disorders         
Adverse drug reaction  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Asthenia  1  2/383 (0.52%)  2/384 (0.52%)  1/123 (0.81%)  5/890 (0.56%) 
Chest pain  1  3/383 (0.78%)  7/384 (1.82%)  1/123 (0.81%)  11/890 (1.24%) 
Device occlusion  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Drug resistance  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haemorrhagic cyst  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hyperthermia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Hyperthermia malignant  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Hypothermia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Impaired healing  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Non-cardiac chest pain  1  6/383 (1.57%)  5/384 (1.30%)  1/123 (0.81%)  12/890 (1.35%) 
Pyrexia  1  2/383 (0.52%)  2/384 (0.52%)  3/123 (2.44%)  7/890 (0.79%) 
Sudden death  1  1/383 (0.26%)  1/384 (0.26%)  1/123 (0.81%)  3/890 (0.34%) 
Thrombosis in device  1  1/383 (0.26%)  0/384 (0.00%)  2/123 (1.63%)  3/890 (0.34%) 
Hepatobiliary disorders         
Bile duct stone  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Biliary colic  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cholangitis acute  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Cholecystitis  1  2/383 (0.52%)  3/384 (0.78%)  0/123 (0.00%)  5/890 (0.56%) 
Cholelithiasis  1  1/383 (0.26%)  2/384 (0.52%)  0/123 (0.00%)  3/890 (0.34%) 
Hepatic cirrhosis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hepatitis acute  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hepatotoxicity  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Immune system disorders         
Drug hypersensitivity  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Hypersensitivity  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Seasonal allergy  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Infections and infestations         
Abdominal wall abscess  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Abscess limb  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Acinetobacter bacteraemia  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Acinetobacter infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Appendicitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Arteriovenous graft site infection  1  1/383 (0.26%)  1/384 (0.26%)  2/123 (1.63%)  4/890 (0.45%) 
Bacteraemia  1  2/383 (0.52%)  2/384 (0.52%)  0/123 (0.00%)  4/890 (0.45%) 
Bacterial sepsis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Bacterial tracheitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Bronchitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Bronchopneumonia  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Campylobacter gastroenteritis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Cellulitis  1  8/383 (2.09%)  4/384 (1.04%)  1/123 (0.81%)  13/890 (1.46%) 
Clostridium difficile colitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Clostridium difficile infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Cystitis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Device related infection  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Device related sepsis  1  1/383 (0.26%)  1/384 (0.26%)  1/123 (0.81%)  3/890 (0.34%) 
Diabetic gangrene  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Diverticulitis  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Endocarditis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Enteritis infectious  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Erysipelas  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Escherichia bacteraemia  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Gangrene  1  0/383 (0.00%)  0/384 (0.00%)  2/123 (1.63%)  2/890 (0.22%) 
Gastroenteritis  1  6/383 (1.57%)  0/384 (0.00%)  0/123 (0.00%)  6/890 (0.67%) 
Gastroenteritis viral  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Genital abscess  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Graft infection  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Helicobacter gastritis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Herpes zoster  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Infected skin ulcer  1  3/383 (0.78%)  1/384 (0.26%)  0/123 (0.00%)  4/890 (0.45%) 
Infectious mononucleosis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Influenza  1  3/383 (0.78%)  1/384 (0.26%)  2/123 (1.63%)  6/890 (0.67%) 
Intervertebral discitis  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Localised infection  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Lower respiratory tract infection  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Osteomyelitis  1  4/383 (1.04%)  3/384 (0.78%)  1/123 (0.81%)  8/890 (0.90%) 
Osteomyelitis acute  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Perirectal abscess  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Peritonitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pneumonia  1  7/383 (1.83%)  5/384 (1.30%)  3/123 (2.44%)  15/890 (1.69%) 
Pneumonia bacterial  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Postoperative wound infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Renal cyst infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Respiratory tract infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Sepsis  1  10/383 (2.61%)  2/384 (0.52%)  3/123 (2.44%)  15/890 (1.69%) 
Septic shock  1  3/383 (0.78%)  1/384 (0.26%)  2/123 (1.63%)  6/890 (0.67%) 
Shunt infection  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Skin infection  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Staphylococcal bacteraemia  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Staphylococcal sepsis  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Subcutaneous abscess  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Tracheitis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Tracheobronchitis  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Upper respiratory tract infection  1  1/383 (0.26%)  1/384 (0.26%)  1/123 (0.81%)  3/890 (0.34%) 
Urinary tract infection  1  1/383 (0.26%)  2/384 (0.52%)  1/123 (0.81%)  4/890 (0.45%) 
Urosepsis  1  1/383 (0.26%)  2/384 (0.52%)  0/123 (0.00%)  3/890 (0.34%) 
Viral infection  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Viral upper respiratory tract infection  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Wound infection  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Wound sepsis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Arteriovenous fistula occlusion  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Arteriovenous fistula site complication  1  7/383 (1.83%)  6/384 (1.56%)  0/123 (0.00%)  13/890 (1.46%) 
Arteriovenous fistula site haemorrhage  1  3/383 (0.78%)  4/384 (1.04%)  1/123 (0.81%)  8/890 (0.90%) 
Arteriovenous fistula thrombosis  1  4/383 (1.04%)  6/384 (1.56%)  0/123 (0.00%)  10/890 (1.12%) 
Cervical vertebral fracture  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Clavicle fracture  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Complications of transplanted kidney  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Compression fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Contusion  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Coronary bypass thrombosis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Dialysis related complication  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Facial bones fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Fall  1  0/383 (0.00%)  2/384 (0.52%)  1/123 (0.81%)  3/890 (0.34%) 
Femoral neck fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Femur fracture  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Foot fracture  1  3/383 (0.78%)  0/384 (0.00%)  0/123 (0.00%)  3/890 (0.34%) 
Graft thrombosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haemodialysis-induced symptom  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Hip fracture  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Humerus fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Intentional overdose  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Jaw fracture  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Lower limb fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Lumbar vertebral fracture  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Multiple fractures  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Patella fracture  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Peripheral arterial reocclusion  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Perirenal haematoma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Post procedural complication  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Post procedural haematoma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Postoperative respiratory failure  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Procedural hypotension  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Radius fracture  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Shunt stenosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Shunt thrombosis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Soft tissue injury  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Splenic injury  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Stoma site pain  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Subdural haematoma  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Thermal burn  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Tibia fracture  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Toxicity to various agents  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Vascular access complication  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Vascular graft complication  1  0/383 (0.00%)  2/384 (0.52%)  2/123 (1.63%)  4/890 (0.45%) 
Vascular graft thrombosis  1  4/383 (1.04%)  2/384 (0.52%)  2/123 (1.63%)  8/890 (0.90%) 
Vascular pseudoaneurysm  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Wound  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Wound complication  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Wound dehiscence  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Wound haemorrhage  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Investigations         
Alanine aminotransferase increased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Anticoagulation drug level below therapeutic  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Aspartate aminotransferase increased  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Bilirubin conjugated increased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Blood alkaline phosphatase increased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Blood bilirubin increased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Blood calcium decreased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Blood pressure increased  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hepatitis C antibody positive  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
International normalised ratio increased  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Troponin increased  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Weight decreased  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Metabolism and nutrition disorders         
Dehydration  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Diabetes mellitus  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Diabetic ketoacidosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Failure to thrive  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Fluid overload  1  3/383 (0.78%)  8/384 (2.08%)  4/123 (3.25%)  15/890 (1.69%) 
Hyperkalaemia  1  14/383 (3.66%)  10/384 (2.60%)  5/123 (4.07%)  29/890 (3.26%) 
Hypervolaemia  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Hypocalcaemia  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Hypoglycaemia  1  5/383 (1.31%)  4/384 (1.04%)  1/123 (0.81%)  10/890 (1.12%) 
Hypophosphataemia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Malnutrition  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Metabolic acidosis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Arthritis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Bone pain  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Bursitis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Flank pain  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Joint swelling  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Musculoskeletal chest pain  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Musculoskeletal pain  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Neuropathic arthropathy  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Osteoarthritis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pain in extremity  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Rhabdomyolysis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Rotator cuff syndrome  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Spinal osteoarthritis  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Spinal pain  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Bladder adenocarcinoma stage unspecified  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Breast cancer  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Clear cell renal cell carcinoma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Colon cancer stage II  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Lung cancer metastatic  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Metastases to spine  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Neoplasm malignant  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Pancreatic carcinoma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Prostate cancer  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Sarcoma  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Squamous cell carcinoma of skin  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Thyroid neoplasm  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Nervous system disorders         
Altered state of consciousness  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Ataxia  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Carotid artery stenosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cerebral haemorrhage  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cerebral infarction  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Cerebrovascular accident  1  3/383 (0.78%)  1/384 (0.26%)  0/123 (0.00%)  4/890 (0.45%) 
Dizziness  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Encephalopathy  1  0/383 (0.00%)  3/384 (0.78%)  1/123 (0.81%)  4/890 (0.45%) 
Generalised tonic-clonic seizure  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haemorrhage intracranial  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Headache  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Hemiparesis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Hypoaesthesia  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Hypoxic-ischaemic encephalopathy  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Loss of consciousness  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Meralgia paraesthetica  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Metabolic encephalopathy  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Migraine  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Presyncope  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Seizure  1  3/383 (0.78%)  1/384 (0.26%)  0/123 (0.00%)  4/890 (0.45%) 
Subarachnoid haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Syncope  1  6/383 (1.57%)  2/384 (0.52%)  3/123 (2.44%)  11/890 (1.24%) 
Transient ischaemic attack  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Tremor  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Psychiatric disorders         
Confusional state  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Delirium  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Depression  1  0/383 (0.00%)  2/384 (0.52%)  1/123 (0.81%)  3/890 (0.34%) 
Depression suicidal  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hallucination, visual  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Mental status changes  1  6/383 (1.57%)  0/384 (0.00%)  2/123 (1.63%)  8/890 (0.90%) 
Renal and urinary disorders         
Azotaemia  1  2/383 (0.52%)  2/384 (0.52%)  0/123 (0.00%)  4/890 (0.45%) 
Chronic kidney disease  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haematuria  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Nephrolithiasis  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Nephrosclerosis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Renal colic  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Renal cyst haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Renal impairment  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Menorrhagia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Pelvic haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Postmenopausal haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Respiratory, thoracic and mediastinal disorders         
Acute pulmonary oedema  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Acute respiratory failure  1  2/383 (0.52%)  1/384 (0.26%)  0/123 (0.00%)  3/890 (0.34%) 
Aspiration  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Asthma  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Bronchospasm  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Chronic obstructive pulmonary disease  1  1/383 (0.26%)  1/384 (0.26%)  0/123 (0.00%)  2/890 (0.22%) 
Cough  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Dyspnoea  1  0/383 (0.00%)  3/384 (0.78%)  1/123 (0.81%)  4/890 (0.45%) 
Dyspnoea exertional  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Epistaxis  1  1/383 (0.26%)  1/384 (0.26%)  1/123 (0.81%)  3/890 (0.34%) 
Hypoxia  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Pleural effusion  1  2/383 (0.52%)  2/384 (0.52%)  0/123 (0.00%)  4/890 (0.45%) 
Pneumonia aspiration  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pulmonary cavitation  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Pulmonary congestion  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pulmonary embolism  1  1/383 (0.26%)  2/384 (0.52%)  1/123 (0.81%)  4/890 (0.45%) 
Pulmonary infarction  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pulmonary mass  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Pulmonary oedema  1  1/383 (0.26%)  3/384 (0.78%)  0/123 (0.00%)  4/890 (0.45%) 
Respiratory arrest  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Respiratory failure  1  3/383 (0.78%)  2/384 (0.52%)  0/123 (0.00%)  5/890 (0.56%) 
Stridor  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Throat tightness  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Decubitus ulcer  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Diabetic foot  1  1/383 (0.26%)  2/384 (0.52%)  2/123 (1.63%)  5/890 (0.56%) 
Henoch-Schonlein purpura  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Purpura  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Skin ulcer  1  1/383 (0.26%)  5/384 (1.30%)  0/123 (0.00%)  6/890 (0.67%) 
Vasculitic rash  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Surgical and medical procedures         
Arteriovenous graft  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Therapy cessation  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Vascular disorders         
Aortic aneurysm  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Aortic stenosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Arterial occlusive disease  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Deep vein thrombosis  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Dry gangrene  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Extremity necrosis  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Haematoma  1  2/383 (0.52%)  0/384 (0.00%)  0/123 (0.00%)  2/890 (0.22%) 
Haemorrhage  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hypertension  1  5/383 (1.31%)  4/384 (1.04%)  1/123 (0.81%)  10/890 (1.12%) 
Hypertensive crisis  1  0/383 (0.00%)  1/384 (0.26%)  1/123 (0.81%)  2/890 (0.22%) 
Hypertensive emergency  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Hypotension  1  5/383 (1.31%)  4/384 (1.04%)  2/123 (1.63%)  11/890 (1.24%) 
Jugular vein thrombosis  1  0/383 (0.00%)  0/384 (0.00%)  1/123 (0.81%)  1/890 (0.11%) 
Malignant hypertension  1  0/383 (0.00%)  2/384 (0.52%)  0/123 (0.00%)  2/890 (0.22%) 
Orthostatic hypotension  1  1/383 (0.26%)  0/384 (0.00%)  1/123 (0.81%)  2/890 (0.22%) 
Peripheral arterial occlusive disease  1  2/383 (0.52%)  1/384 (0.26%)  1/123 (0.81%)  4/890 (0.45%) 
Peripheral vascular disorder  1  2/383 (0.52%)  4/384 (1.04%)  0/123 (0.00%)  6/890 (0.67%) 
Shock haemorrhagic  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Steal syndrome  1  1/383 (0.26%)  0/384 (0.00%)  0/123 (0.00%)  1/890 (0.11%) 
Vasculitis  1  0/383 (0.00%)  1/384 (0.26%)  0/123 (0.00%)  1/890 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
20120229 / 20120230 Placebo 20120229 / 20120230 Etelcalcetide 20120359 Etelcalcetide Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   289/383 (75.46%)   249/384 (64.84%)   75/123 (60.98%)   613/890 (68.88%) 
Gastrointestinal disorders         
Abdominal pain  1  22/383 (5.74%)  12/384 (3.13%)  3/123 (2.44%)  37/890 (4.16%) 
Diarrhoea  1  41/383 (10.70%)  46/384 (11.98%)  8/123 (6.50%)  95/890 (10.67%) 
Nausea  1  43/383 (11.23%)  27/384 (7.03%)  13/123 (10.57%)  83/890 (9.33%) 
Vomiting  1  40/383 (10.44%)  37/384 (9.64%)  11/123 (8.94%)  88/890 (9.89%) 
Infections and infestations         
Bronchitis  1  20/383 (5.22%)  6/384 (1.56%)  2/123 (1.63%)  28/890 (3.15%) 
Nasopharyngitis  1  19/383 (4.96%)  21/384 (5.47%)  3/123 (2.44%)  43/890 (4.83%) 
Upper respiratory tract infection  1  20/383 (5.22%)  14/384 (3.65%)  20/123 (16.26%)  54/890 (6.07%) 
Injury, poisoning and procedural complications         
Arteriovenous fistula site complication  1  22/383 (5.74%)  27/384 (7.03%)  8/123 (6.50%)  57/890 (6.40%) 
Fall  1  22/383 (5.74%)  14/384 (3.65%)  6/123 (4.88%)  42/890 (4.72%) 
Procedural hypotension  1  17/383 (4.44%)  8/384 (2.08%)  8/123 (6.50%)  33/890 (3.71%) 
Investigations         
Blood calcium decreased  1  226/383 (59.01%)  129/384 (33.59%)  30/123 (24.39%)  385/890 (43.26%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  19/383 (4.96%)  18/384 (4.69%)  10/123 (8.13%)  47/890 (5.28%) 
Back pain  1  26/383 (6.79%)  20/384 (5.21%)  4/123 (3.25%)  50/890 (5.62%) 
Muscle spasms  1  36/383 (9.40%)  33/384 (8.59%)  10/123 (8.13%)  79/890 (8.88%) 
Pain in extremity  1  16/383 (4.18%)  23/384 (5.99%)  6/123 (4.88%)  45/890 (5.06%) 
Nervous system disorders         
Headache  1  25/383 (6.53%)  25/384 (6.51%)  2/123 (1.63%)  52/890 (5.84%) 
Psychiatric disorders         
Anxiety  1  8/383 (2.09%)  10/384 (2.60%)  7/123 (5.69%)  25/890 (2.81%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  21/383 (5.48%)  20/384 (5.21%)  13/123 (10.57%)  54/890 (6.07%) 
Dyspnoea  1  24/383 (6.27%)  17/384 (4.43%)  5/123 (4.07%)  46/890 (5.17%) 
Vascular disorders         
Hypertension  1  30/383 (7.83%)  18/384 (4.69%)  10/123 (8.13%)  58/890 (6.52%) 
Hypotension  1  36/383 (9.40%)  25/384 (6.51%)  5/123 (4.07%)  66/890 (7.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
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Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01785875     History of Changes
Other Study ID Numbers: 20120231
KAI-4169-008 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002808-41 ( EudraCT Number )
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: February 7, 2017
Results First Posted: March 27, 2017
Last Update Posted: April 10, 2019