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Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet Group | Experimental | Cinacalcet plus low dose active Vitamin D (if prescribed) |
|
| Control Group | Active Comparator | Flexible active vitamin D dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinacalcet | Drug | Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23365129 | Background | Rodriguez M, Urena-Torres P, Petavy F, Cooper K, Farouk M, Goodman WG. Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients. J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30. | |
| 23328710 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Once participants were determined to be eligible for the study, they entered a pre-randomization wash-out phase of 4 weeks (if receiving vitamin D at the time of enrollment). Four enrolled participants did not complete the pre-randomization wash-out phase and were not randomized into the study.
First participant was enrolled on 19 February 2009 and last participant completed the study on 5 July 2011. 313 participants were enrolled from 82 study centers in US, Europe, Canada, Australia and Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cinacalcet | cinacalcet in combination with low-dose active vitamin D (if prescribed) |
| FG001 | Control Group | Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cinacalcet | cinacalcet in combination with low-dose active vitamin D (if prescribed) |
| BG001 | Control Group | Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26 | Posted | Number | participants | Weeks 22-26 |
|
56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
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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 | Cinacalcet | cinacalcet in combination with low-dose active vitamin D (if prescribed) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
This was an open-label study and neither investigators nor subjects were blinded to treatment modality. Cinacalcet was dosed by forced titration. Active vitamin D administration was at the discretion of the investigator in each treatment arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Vitamin D | Drug | Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism. |
|
|
| Weeks 22-26 |
| Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 and Weeks 48-52 |
| Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 and Weeks 48-52 |
| Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 and Weeks 48-52 |
| Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 and Weeks 48-52 |
| Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 22-26 |
| Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Weeks 48-52 |
| Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Weeks 22-26 |
| Subject Incidence of Hypercalcemia During the Maintenance Phase | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Weeks 26-48 |
| Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Weeks 48-52 |
| Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Weeks 22-26 |
| Subject Incidence of Hyperphosphatemia During the Maintenance Phase | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Weeks 26-48 |
| Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Weeks 48-52 |
| Urena-Torres P, Bridges I, Christiano C, Cournoyer SH, Cooper K, Farouk M, Kopyt NP, Rodriguez M, Zehnder D, Covic A. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013 May;28(5):1241-54. doi: 10.1093/ndt/gfs568. Epub 2013 Jan 16. |
| Death |
|
| Lost to Follow-up |
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| Withdrawal by Subject |
|
| "Other" in electronic Case Report Form |
|
| Protocol criteria (other) |
|
| Protocol criteria (renal transplant) |
|
| Administrative decision |
|
| Protocol criteria (parathyroidectomy) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Active Vitamin D Use | Active Vitamin D use at baseline | Number | participants |
|
| iPTH | iPTH value at baseline | Mean | Standard Deviation | pg/mL |
|
| Corrected Serum Calcium | Corrected serum calcium at baseline | Mean | Standard Deviation | mg/dL |
|
| Serum Phosphorus | serum phosphorus at baseline | Mean | Standard Deviation | mg/dL |
|
| Albumin | Albumin at baseline | Mean | Standard Deviation | g/dL |
|
| Dialysis Vintage | Time since dialysis started | Mean | Standard Deviation | months |
|
| OG001 | Control Group | Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines. |
|
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| Secondary | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26 | Posted | Number | participants | Weeks 22-26 |
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| Secondary | Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52 | Posted | Number | participants | Weeks 48-52 |
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| Secondary | Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52 | Posted | Number | participants | Weeks 48-52 |
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| Secondary | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26 | Posted | Number | participants | Weeks 22-26 |
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| Secondary | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52 | Posted | Number | participants | Weeks 48-52 |
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| Secondary | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) | All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26 | Posted | Number | participants | Weeks 22-26 |
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| Secondary | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52 | Posted | Number | participants | Weeks 48-52 |
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| Secondary | Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases | Posted | Number | participants | Weeks 22-26 and Weeks 48-52 |
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| Secondary | Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases | Posted | Number | participants | Weeks 22-26 and Weeks 48-52 |
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| Secondary | Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases | Posted | Number | participants | Weeks 22-26 and Weeks 48-52 |
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| Secondary | Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases | Posted | Number | participants | Weeks 22-26 and Weeks 48-52 |
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| Secondary | Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | Weeks 22-26 |
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| Secondary | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 22-26 |
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| Secondary | Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | Weeks 48-52 |
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| Secondary | Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 48-52 |
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| Secondary | Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 22-26 |
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|
|
| Secondary | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 22-26 |
|
|
|
|
| Secondary | Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 48-52 |
|
|
|
|
| Secondary | Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 48-52 |
|
|
|
|
| Secondary | Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 22-26 |
|
|
|
|
| Secondary | Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 22-26 |
|
|
|
|
| Secondary | Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 48-52 |
|
|
|
|
| Secondary | Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase | All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Weeks 48-52 |
|
|
|
|
| Secondary | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest. | Posted | Number | participants | Weeks 22-26 |
|
|
|
| Secondary | Subject Incidence of Hypercalcemia During the Maintenance Phase | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest. | Posted | Number | participants | Weeks 26-48 |
|
|
|
| Secondary | Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 | Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest. | Posted | Number | participants | Weeks 48-52 |
|
|
|
| Secondary | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest. | Posted | Number | participants | Weeks 22-26 |
|
|
|
| Secondary | Subject Incidence of Hyperphosphatemia During the Maintenance Phase | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest. | Posted | Number | participants | Weeks 26-48 |
|
|
|
| Secondary | Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 | Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL | Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest. | Posted | Number | participants | Weeks 48-52 |
|
|
|
| 72 |
| 155 |
| 107 |
| 155 |
| EG001 | Control Group | Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines. | 52 | 154 | 87 | 154 |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nodal arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericarditis uraemic | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site discharge | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous graft site infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis gangrenous | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Groin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Septic embolus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Chemical burn of skin | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Cerebellar tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Transverse sinus thrombosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal cyst ruptured | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal septum perforation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Poor peripheral circulation | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Steal syndrome | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Venous stenosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |