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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005051-28 | EudraCT Number |
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This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etelcalcetide | Experimental | Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Common Treatment-emergent Adverse Events | 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. | 30 days |
| Change From Baseline in Serum Corrected Calcium Concentration Over Time | 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]). | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
| Change From Baseline in Serum Phosphorus Concentration at End of Study | Baseline and day 30 (end of study) | |
| Change From Baseline in Serum Potassium Concentration at End of Study | Baseline and day 30 (end of study) | |
| Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | |
| Change From Baseline in Heart Rate at End of Study | Baseline and day 30 (end of study) | |
| Change From Baseline in Temperature at End of Study | Baseline and day 30 (end of study) | |
| Change From Baseline in Blood Pressure at End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Total Calcium Concentration | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | |
| Change From Baseline in Serum Ionized Calcium Concentration | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90095 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32647975 | Derived | Sohn W, Salusky IB, Schmitt CP, Taylan C, Walle JV, Ngang J, Yan L, Kroenke M, Warady BA. Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis. Pediatr Nephrol. 2021 Jan;36(1):133-142. doi: 10.1007/s00467-020-04599-z. Epub 2020 Jul 9. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etelcalcetide | Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2016 | Apr 23, 2019 |
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|
| Baseline and day 30 (end of study) |
| Change From Baseline in PR Interval at End of Study | Baseline and day 30 (end of study) |
| Change From Baseline in QRS Interval at End of Study | Baseline and day 30 (end of study) |
| Change From Baseline in QT Interval at End of Study | Baseline and day 30 (end of study) |
| Change From Baseline in Corrected (Bazett) QT Interval at End of Study | Baseline and day 30 (end of study) |
| Change From Baseline in Corrected (Fridericia) QT Interval at End of Study | Baseline and day 30 (end of study) |
| Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
| Time to Maximum Concentration (Tmax) of Etelcalcetide | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | 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. | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) | 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. | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
| Terminal Half-life (T1/2,z) of Etelcalcetide | 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. | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
| Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies | 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. | Baseline and day 30 |
| Number of Participants With Treatment-emergent Adverse Events | 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. | 30 days |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Research Site | Kansas City | Missouri | 64108 | United States |
| Research Site | Brussels | 1020 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Cologne | 50937 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | Vilinus | 08406 | Lithuania |
| Research Site | Krakow | 30-663 | Poland |
| Research Site | London | WC1N 3JH | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etelcalcetide | Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Serum Corrected Calcium Concentration | 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]). | Mean | Standard Deviation | mmol/L |
| ||||||||||||||||
| Serum Phosphorus Concentration | Participants with available data | Mean | Standard Deviation | mmol/L |
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| Serum Potassium Concentration | Mean | Standard Deviation | mmol/L |
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| Serum Intact Parathyroid Hormone Concentration | Mean | Standard Deviation | pmol/L |
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| Serum Calcium Concentration | Mean | Standard Deviation | mmol/L |
| |||||||||||||||||
| Serum Ionized Calcium Concentration | Mean | Standard Deviation | mmol/L |
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| Heart Rate | Mean | Standard Deviation | beats/minute |
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| Temperature | Mean | Standard Deviation | degrees celsius |
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| Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||||
| PR Interval | 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. | Mean | Standard Deviation | ms |
| ||||||||||||||||
| QRS Interval | 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. | Mean | Standard Deviation | ms |
| ||||||||||||||||
| QT Interval | 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. | Mean | Standard Deviation | ms |
| ||||||||||||||||
| Corrected (Bazett) QT Interval (QTcB) | Mean | Standard Deviation | ms |
| |||||||||||||||||
| Corrected (Fridericia) QT Interval (QTcF) | Mean | Standard Deviation | ms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Common Treatment-emergent Adverse Events | 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. | Participants who received at least 1 dose of etelcalcetide (safety analysis set) | Posted | Count of Participants | Participants | 30 days |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Serum Corrected Calcium Concentration Over Time | 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]). | Treated participants with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Serum Phosphorus Concentration at End of Study | Treated participants | Posted | Mean | Standard Deviation | mmol/L | Baseline and day 30 (end of study) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Serum Potassium Concentration at End of Study | Treated participants | Posted | Mean | Standard Deviation | mmol/L | Baseline and day 30 (end of study) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Treated participants with available data at each time point. | Posted | Mean | Standard Deviation | pmol/L | Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
|
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| Primary | Change From Baseline in Heart Rate at End of Study | Treated participants | Posted | Mean | Standard Deviation | beats/minute | Baseline and day 30 (end of study) |
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| Primary | Change From Baseline in Temperature at End of Study | Treated participants | Posted | Mean | Standard Deviation | degrees celsius | Baseline and day 30 (end of study) |
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| Primary | Change From Baseline in Blood Pressure at End of Study | Treated participants | Posted | Mean | Standard Deviation | mmHg | Baseline and day 30 (end of study) |
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| Primary | Change From Baseline in PR Interval at End of Study | Treated participants | Posted | Mean | Standard Deviation | ms | Baseline and day 30 (end of study) |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QRS Interval at End of Study | Treated participants | Posted | Mean | Standard Deviation | ms | Baseline and day 30 (end of study) |
|
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| Primary | Change From Baseline in QT Interval at End of Study | Treated participants | Posted | Mean | Standard Deviation | ms | Baseline and day 30 (end of study) |
|
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| Primary | Change From Baseline in Corrected (Bazett) QT Interval at End of Study | Treated participants | Posted | Mean | Standard Deviation | ms | Baseline and day 30 (end of study) |
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| Primary | Change From Baseline in Corrected (Fridericia) QT Interval at End of Study | Treated participants | Posted | Mean | Standard Deviation | ms | Baseline and day 30 (end of study) |
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| Secondary | Change From Baseline in Serum Total Calcium Concentration | Treated participants with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
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| Secondary | Change From Baseline in Serum Ionized Calcium Concentration | Treated participants with available data at each time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. | The pharmacokinetic analysis set | Posted | Mean | Standard Deviation | ng/mL | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
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| Secondary | Time to Maximum Concentration (Tmax) of Etelcalcetide | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. | The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected. | Posted | Median | Full Range | hours | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
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| Secondary | Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | 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. | Pharmacokinetic analysis set | Posted | Mean | Standard Deviation | hr*ng/mL | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
|
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| Secondary | Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) | 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. | Pharmacokinetic analysis set with available AUCinf data | Posted | Mean | Standard Deviation | hr*ng/mL | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
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| Secondary | Terminal Half-life (T1/2,z) of Etelcalcetide | 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. | Pharmacokinetic analysis set with available T1/2,z data | Posted | Mean | Standard Deviation | days | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose |
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| Secondary | Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies | 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. | Treated participants | Posted | Count of Participants | Participants | Baseline and day 30 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events | 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. | All Treated participants | Posted | Count of Participants | Participants | 30 days |
|
|
30 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etelcalcetide | Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. | 0 | 11 | 0 | 11 | 6 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Calcium ionised decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Catheter placement | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
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| Gastrostomy | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2016 | Apr 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
Not provided
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| Unknown or Not Reported |
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