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| Name | Class |
|---|---|
| Abbott Japan Co.,Ltd | INDUSTRY |
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The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Experimental | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
|
| Paricalcitol 2 µg ± 2 µg | Experimental | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
|
| Paricalcitol 4 µg ± 1 µg | Experimental | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
|
| Paricalcitol 4 µg ± 2 µg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With of Hypercalcemia | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study. | Anytime during the study through Week 53 |
| The Percentage of Participants With Hyperphosphatemia | The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study. | Anytime during the study through Week 53 |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change in Intact Parathyroid Hormone (iPTH) | From Baseline to Final Visit (which could occur anytime between study initiation and Week 53) | |
| The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Hypercalcemia | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53) | Anytime from Week 13 through Week 53 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moriaki KUBO | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
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| Label | URL |
|---|---|
| prescribing information | View source |
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One of the 107 subjects withdrew consent before receiving study drug in this study. 106 subjects were treated with study drug. Two of these subjects were not included in the Full Analysis Set for analysis of efficacy because of subject death (n = 1) and withdrawal of consent (n = 1).
A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol 2 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| FG001 | Paricalcitol 2 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| FG002 | Paricalcitol 4 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| FG003 | Paricalcitol 4 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol 2 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Percentage of Participants With of Hypercalcemia | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study. | All subjects who received at least 1 dose of paricalcitol in this study. | Posted | Number | Percentage of participants | Anytime during the study through Week 53 |
|
All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form.
Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol 2 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
Not provided
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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| Experimental |
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
|
|
| From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53) |
| Change in Mean iPTH | Every week from Baseline through Week 13 and every other week thereafter until Week 53 |
| Duration of 2 Consecutive Decreases in iPTH >= 50% | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| Duration of 2 Consecutive iPTH Values <= 180 pg/mL | From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53) |
| The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
| Chiba |
| Japan |
| Fukuoka | Japan |
| Hokkaido | Japan |
| Ibaraki | Japan |
| Kanagawa | Japan |
| Kumamoto | Japan |
| Nagano | Japan |
| Nagasaki | Japan |
| Osaka | Japan |
| Saitama | Japan |
| Tokyo | Japan |
| Adverse Event |
|
| Missed 7 consecutive doses |
|
| Admitted to hospital for 2 weeks |
|
| Physician decision, change of therapy |
|
| Difficult to travel to dialysis site |
|
| Resumption criteria were not met |
|
| BG001 | Paricalcitol 2 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| BG002 | Paricalcitol 4 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| BG003 | Paricalcitol 4 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Paricalcitol 2 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| OG002 | Paricalcitol 4 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| OG003 | Paricalcitol 4 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
|
|
| Primary | The Percentage of Participants With Hyperphosphatemia | The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study. | All subjects who received at least 1 dose of paricalcitol in this study. | Posted | Number | Percentage of participants | Anytime during the study through Week 53 |
|
|
|
| Secondary | The Mean Change in Intact Parathyroid Hormone (iPTH) | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Mean | 95% Confidence Interval | picograms/milliliter (pg/mL) | From Baseline to Final Visit (which could occur anytime between study initiation and Week 53) |
|
|
|
| Secondary | The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Number | Percentage of participants | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
|
|
|
| Secondary | The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Number | Percentage of Participants | Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53) |
|
|
|
| Secondary | Change in Mean iPTH | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Mean | Standard Deviation | pg/mL | Every week from Baseline through Week 13 and every other week thereafter until Week 53 |
|
|
|
| Secondary | Duration of 2 Consecutive Decreases in iPTH >= 50% | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Mean | Standard Deviation | days | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
|
|
|
| Secondary | Duration of 2 Consecutive iPTH Values <= 180 pg/mL | All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set. | Posted | Mean | Standard Deviation | days | From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53) |
|
|
|
| Other Pre-specified | The Percentage of Participants With Hypercalcemia | The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53) | Posted | Number | Percentage of participants | Anytime from Week 13 through Week 53 |
|
|
|
| Secondary | The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit | All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline. | Posted | Number | Percentage of participants | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
|
|
|
| Secondary | The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit | All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline. | Posted | Number | Percentage of participants | From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) |
|
|
|
| 8 |
| 27 |
| 27 |
| 27 |
| EG001 | Paricalcitol 2 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 6 | 30 | 30 | 30 |
| EG002 | Paricalcitol 4 µg ± 1 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 6 | 23 | 23 | 23 |
| EG003 | Paricalcitol 4 µg ± 2 µg | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. | 4 | 26 | 26 | 26 |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Shunt aneurysm | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Spondylolithesis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Puncture site haemorrhage | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Bleeding time prolonged | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Eosinophil percentage increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Subjects with decrease in iPTH >= 50% |
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