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| Name | Class |
|---|---|
| Assign Data Management and Biostatistics GmbH | OTHER |
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The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis. SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels. Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment. Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium. Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol IV | Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range | Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL). | Baseline and Months 3, 6, 12, 18, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hypercalcemia | Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit. | Baseline and Months 3, 6, 12, 18, and 24 |
| Percentage of Participants With Hyperphosphatemia |
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Inclusion Criteria:
Patients aged at least 18 years
Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
Exclusion Criteria:
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Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Dworan-Timler | AbbVie Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27447 | Graz | 8010 | Austria | |||
| Site Reference ID/Investigator# 49182 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol IV | Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit. |
| Baseline and Months 3, 6, 12, 18, and 24 |
| Percentage of Participants With at Least a 30%-Reduction in iPTH Levels | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level. | Baseline and Months 3, 6, 12, 18, and 24 |
| Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits. | Baseline to Month 24 |
| Percentage of Participants With at Least One Concomitant Medication | The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
| 24 months |
| Percentage of Participants Experiencing Hospitalization | The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study. | 24 months |
| Number of Participants With Cardiac Disease Progression | Cardiac disease progression was determined by the Investigator. | Month 3, 6, 12, 18, and 24 |
| Graz |
| 8020 |
| Austria |
| Site Reference ID/Investigator# 27483 | Graz | 80360 | Austria |
| Site Reference ID/Investigator# 52742 | Graz | 8052 | Austria |
| Site Reference ID/Investigator# 27487 | Innsbruck | 6020 | Austria |
| Site Reference ID/Investigator# 36983 | Linz | 4010 | Austria |
| Site Reference ID/Investigator# 27484 | Linz | 4020 | Austria |
| Site Reference ID/Investigator# 27485 | Rottenmann | 8786 | Austria |
| Site Reference ID/Investigator# 27446 | Vienna | 1030 | Austria |
| Site Reference ID/Investigator# 53469 | Vienna | 1090 | Austria |
| Site Reference ID/Investigator# 27482 | Vienna | 1130 | Austria |
| Site Reference ID/Investigator# 10981 | Vienna | 1220 | Austria |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol IV | Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Blood Pressure | Blood pressure data were available for 66 participants | Mean | Standard Deviation | mm Hg |
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| 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 | Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range | Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL). | Intent-to-treat population; last observation carried forward (LOCF) imputation was used. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, and 24 |
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| Secondary | Percentage of Participants With Hypercalcemia | Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit. | Intent-to-treat; LOCF was used | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, and 24 |
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| Secondary | Percentage of Participants With Hyperphosphatemia | Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit. | Intent-to-treat; LOCF was used. "n" indicates the number of participants with available data at each time point. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, and 24 |
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| Secondary | Percentage of Participants With at Least a 30%-Reduction in iPTH Levels | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level. | Intent-to-treat; LOCF was used. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, and 24 |
|
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| Secondary | Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits. | Intent-to-treat | Posted | Number | percentage of participants | Baseline to Month 24 |
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| Secondary | Percentage of Participants With at Least One Concomitant Medication | The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
| Intent-to-treat | Posted | Number | percentage of participants | 24 months |
|
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| Secondary | Percentage of Participants Experiencing Hospitalization | The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study. | Intent-to-treat | Posted | Number | percentage of participants | 24 months |
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| Secondary | Number of Participants With Cardiac Disease Progression | Cardiac disease progression was determined by the Investigator. | Intent-to-treat | Posted | Number | participants | Month 3, 6, 12, 18, and 24 |
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24 months
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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 | Paricalcitol IV | Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years | 31 | 67 | 23 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Muscle abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pancreatic abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
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| Medical device implantation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
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| Stent placement | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiac valve disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Coeliac artery stenosis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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