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Trial record 77 of 108 for:    CALCIUM CATION

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

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ClinicalTrials.gov Identifier: NCT02833857
Recruitment Status : Completed
First Posted : July 14, 2016
Results First Posted : July 10, 2019
Last Update Posted : July 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 Chronic Kidney Disease, Secondary Hyperparathyroidism
Intervention Drug: Etelcalcetide
Enrollment 11
Recruitment Details This study was conducted at 6 centers in the United States, United Kingdom, and the European Union. Participants were enrolled from 14 March 2017 to 01 October 2018.
Pre-assignment Details  
Arm/Group Title Etelcalcetide
Hide Arm/Group Description Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Etelcalcetide
Hide Arm/Group Description Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
10.3  (4.3)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Children (2 to 11 years)
5
  45.5%
Adolescents (12 to 17 years)
6
  54.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
2
  18.2%
Not Hispanic or Latino
9
  81.8%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Black (or African American)
2
  18.2%
White
9
  81.8%
Serum Corrected Calcium Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
2.42  (0.08)
[1]
Measure Description: When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 – serum albumin [g/L]).
Serum Phosphorus Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 10 participants
1.79  (0.45)
[1]
Measure Analysis Population Description: Participants with available data
Serum Potassium Concentration  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
4.77  (0.55)
Serum Intact Parathyroid Hormone Concentration  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 11 participants
66.10  (57.57)
Serum Calcium Concentration  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
2.41  (0.08)
Serum Ionized Calcium Concentration  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
1.16  (0.07)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 11 participants
87.4  (9.9)
Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees celsius
Number Analyzed 11 participants
36.6  (0.3)
Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Systolic blood pressure Number Analyzed 11 participants
119.4  (15.9)
Diastolic blood pressure Number Analyzed 11 participants
66.7  (15.1)
PR Interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 11 participants
133.8  (8.7)
[1]
Measure Description: The PR interval is measured using electrocardiography (ECG) and is the period from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization); it is normally between 120 and 200 milliseconds (ms) in duration.
QRS Interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 11 participants
82.0  (10.9)
[1]
Measure Description: The QRS interval measured during ECG, denotes depolarization of the ventricles, between the beginning of the Q wave and the end of the S wave.
QT Interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 11 participants
363.5  (26.2)
[1]
Measure Description: The QT interval measured during ECG is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval represents electrical depolarization and repolarization of the ventricles.
Corrected (Bazett) QT Interval (QTcB)  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 11 participants
424.2  (29.1)
Corrected (Fridericia) QT Interval (QTcF)  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 11 participants
402.7  (26.1)
1.Primary Outcome
Title Common Treatment-emergent Adverse Events
Hide Description

A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose.

Common adverse events were defined as adverse events occurring in at least 2 participants.

The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of etelcalcetide (safety analysis set)
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
Headache
2
  18.2%
Calcium ionised decreased
2
  18.2%
Hypotension
2
  18.2%
2.Primary Outcome
Title Change From Baseline in Serum Corrected Calcium Concentration Over Time
Hide Description When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 – serum albumin [g/L]).
Time Frame Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at each time point.
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
Day 1, 4 hours Number Analyzed 10 participants
-0.03  (0.12)
Day 3 Number Analyzed 11 participants
-0.03  (0.08)
Day 8 Number Analyzed 11 participants
0.03  (0.09)
Day 10 Number Analyzed 11 participants
0.03  (0.07)
Day 30 Number Analyzed 11 participants
-0.01  (0.16)
3.Primary Outcome
Title Change From Baseline in Serum Phosphorus Concentration at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.08  (0.31)
4.Primary Outcome
Title Change From Baseline in Serum Potassium Concentration at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.45  (1.21)
5.Primary Outcome
Title Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Hide Description [Not Specified]
Time Frame Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at each time point.
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: pmol/L
Day 1, 4 hours Number Analyzed 10 participants
-29.44  (37.16)
Day 3 Number Analyzed 11 participants
-14.81  (37.81)
Day 8 Number Analyzed 11 participants
-10.20  (38.16)
Day 10 Number Analyzed 11 participants
-4.68  (37.92)
Day 30 Number Analyzed 11 participants
-19.81  (51.29)
6.Primary Outcome
Title Change From Baseline in Heart Rate at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: beats/minute
-4.5  (9.3)
7.Primary Outcome
Title Change From Baseline in Temperature at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: degrees celsius
0.1  (0.4)
8.Primary Outcome
Title Change From Baseline in Blood Pressure at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure 0.2  (17.5)
Diastolic blood pressure 3.8  (8.5)
9.Primary Outcome
Title Change From Baseline in PR Interval at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ms
-3.6  (13.9)
10.Primary Outcome
Title Change From Baseline in QRS Interval at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ms
-2.6  (6.8)
11.Primary Outcome
Title Change From Baseline in QT Interval at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ms
2.8  (21.6)
12.Primary Outcome
Title Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ms
-2.1  (32.2)
13.Primary Outcome
Title Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Hide Description [Not Specified]
Time Frame Baseline and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ms
-0.5  (23.3)
14.Secondary Outcome
Title Change From Baseline in Serum Total Calcium Concentration
Hide Description [Not Specified]
Time Frame Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at each time point.
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
Day 1, 4 hours Number Analyzed 10 participants
-0.02  (0.12)
Day 3 Number Analyzed 11 participants
-0.02  (0.08)
Day 8 Number Analyzed 11 participants
0.03  (0.08)
Day 10 Number Analyzed 11 participants
0.02  (0.08)
Day 30 Number Analyzed 11 participants
-0.01  (0.16)
15.Secondary Outcome
Title Change From Baseline in Serum Ionized Calcium Concentration
Hide Description [Not Specified]
Time Frame Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at each time point.
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
Day 1, 4 hours Number Analyzed 10 participants
-0.05  (0.13)
Day 3 Number Analyzed 10 participants
-0.01  (0.08)
Day 8 Number Analyzed 11 participants
0.02  (0.07)
Day 10 Number Analyzed 11 participants
0.01  (0.06)
Day 30 Number Analyzed 11 participants
0.03  (0.06)
16.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Hide Description Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time Frame 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
50.8  (29.3)
17.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of Etelcalcetide
Hide Description Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time Frame 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected.
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: hours
0.17
(0.17 to 0.33)
18.Secondary Outcome
Title Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Hide Description

Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.

Time Frame 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
1360  (1110)
19.Secondary Outcome
Title Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Hide Description

Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method.

Time Frame 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set with available AUCinf data
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
1700  (1420)
20.Secondary Outcome
Title Terminal Half-life (T1/2,z) of Etelcalcetide
Hide Description

Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase.

Time Frame 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set with available T1/2,z data
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: days
5.77  (2.66)
21.Secondary Outcome
Title Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
Hide Description

Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay.

Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline.

Time Frame Baseline and day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
22.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events
Hide Description A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title Etelcalcetide
Hide Arm/Group Description:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
6
  54.5%
Adverse events ≥ grade 3
2
  18.2%
Adverse events ≥ grade 4
0
   0.0%
Serious adverse events
0
   0.0%
AEs leading to discontinuation of etelcalcetide
0
   0.0%
Fatal adverse events
0
   0.0%
Treatment-related adverse events
0
   0.0%
Treatment-related AEs ≥ grade 3
0
   0.0%
Time Frame 30 days
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Etelcalcetide
Hide Arm/Group Description Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
All-Cause Mortality
Etelcalcetide
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Etelcalcetide
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etelcalcetide
Affected / at Risk (%)
Total   6/11 (54.55%) 
Gastrointestinal disorders   
Nausea  1  1/11 (9.09%) 
Vomiting  1  1/11 (9.09%) 
Investigations   
Calcium ionised decreased  1  2/11 (18.18%) 
Nervous system disorders   
Dizziness  1  1/11 (9.09%) 
Headache  1  2/11 (18.18%) 
Paraesthesia  1  1/11 (9.09%) 
Surgical and medical procedures   
Catheter placement  1  1/11 (9.09%) 
Gastrostomy  1  1/11 (9.09%) 
Vascular disorders   
Hypotension  1  2/11 (18.18%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02833857     History of Changes
Other Study ID Numbers: 20140336
2015-005051-28 ( EudraCT Number )
First Submitted: June 9, 2016
First Posted: July 14, 2016
Results First Submitted: April 23, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019