| ID | Type | Description | Link |
|---|---|---|---|
| U01DK062401 | U.S. NIH Grant/Contract | View source | |
| U01DK082230 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Polycystic Kidney Disease Foundation | OTHER |
| University of Pittsburgh |
Not provided
Not provided
Not provided
Not provided
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.
Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
* Specific Aim of Study B
To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).
* Hypothesis to be tested in Study B
In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE-I + placebo | Placebo Comparator | Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg |
|
| ACE-I + ARB | Active Comparator | Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisinopril | Drug | Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. | Patients followed for 5-8 years with average of 6.5 years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Albuminuria | Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years. | up to 8 years (annually assessed) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Schrier, M.D. | University of Colorado, Denver | Study Chair |
| Arlene Chapman, M.D. | Emory University | Principal Investigator |
| Ronald Perrone, M.D. | Tufts University-New England Medical Center | Principal Investigator |
| Vicente Torres, M.D. | Mayo Clinic | Principal Investigator |
| Marva Moxey-Mims, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Charity G Moore, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Aurora | Colorado | 800045 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. | |
| 37250503 | Derived | Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun. |
| Label | URL |
|---|---|
| Polycystic Kidney Disease Foundation Website | View source |
Not provided
Data are available at the NIDDK Central Repository, https://repository.niddk.nih.gov/studies/halt-pkd/?query=halt%20pkd
Not provided
Not provided
Not provided
Not provided
Recruitment for HALT PKD Study B occurred at seven clinical sites between February 2006 and June 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ACE-I + Placebo | ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| FG001 | ACE-I + Angiotensin Receptor Blocker (ARB) | ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACE-I + Placebo | ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| BG001 |
| 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 | Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. | Intention to Treat analysis was used for the primary outcome | Posted | Number | participants | Patients followed for 5-8 years with average of 6.5 years follow up |
|
Serious adverse event data were collected during follow up between 5-8 years with average follow up time of 5.2 years.
Not provided
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 | ACE-I + Placebo | ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vicente Torres | Mayo Clinic | torres.vicente@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D004194 | Disease |
| D016891 | Polycystic Kidney, Autosomal Dominant |
| C537180 | Familial paroxysmal dystonia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017706 | Lisinopril |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| OTHER |
| Washington University School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Telmisartan | Drug | Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
|
|
| Placebo | Drug | Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
|
|
| Aldosterone |
Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years. |
| up at 8 years (annually assessed) |
| Hospitalizations | Hospitalization for any cause | up to 8 years |
| Cardiovascular Hospitalizations | Cause-specific hospitalizations (cardiovascular) | up to 8 years |
| Quality of Life Physical Component Summary | Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years. | up to 8 years (annually assessed) |
| Quality of Life Mental Component Summary | Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years. | up to 8 years (annually assessed) |
| Back or Flank Pain | Report of back or flank pain since the last visit (yes or no) | 48 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Tufts University-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| 25399731 | Derived | Torres VE, Abebe KZ, Chapman AB, Schrier RW, Braun WE, Steinman TI, Winklhofer FT, Brosnahan G, Czarnecki PG, Hogan MC, Miskulin DC, Rahbari-Oskoui FF, Grantham JJ, Harris PC, Flessner MF, Moore CG, Perrone RD; HALT-PKD Trial Investigators. Angiotensin blockade in late autosomal dominant polycystic kidney disease. N Engl J Med. 2014 Dec 11;371(24):2267-76. doi: 10.1056/NEJMoa1402686. Epub 2014 Nov 15. |
| Protocol Violation |
|
| ACE-I + ARB |
ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PKD Genotype | Number | participants |
|
| Age at Diagnosis of Autosomal Dominant Polycystic Kidney Disease (yrs) | Mean | Standard Deviation | years |
|
| Body Mass Index (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Serum Creatinine (mg/dl) | Mean | Standard Deviation | mg/dl |
|
| Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) eGFR (ml/min/m^2) | Mean | Standard Deviation | ml/min/m^2 |
|
|
|
|
| Secondary | Albuminuria | Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | annual percent change | up to 8 years (annually assessed) |
|
|
|
|
| Secondary | Aldosterone | Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years. | Intention to treat analyses | Posted | Mean | 95% Confidence Interval | annual percent change | up at 8 years (annually assessed) |
|
|
|
|
| Secondary | Hospitalizations | Hospitalization for any cause | Intention to treat analysis | Posted | Number | events | up to 8 years |
|
|
|
|
| Secondary | Cardiovascular Hospitalizations | Cause-specific hospitalizations (cardiovascular) | Intention to Treat analysis | Posted | Number | events | up to 8 years |
|
|
|
|
| Secondary | Quality of Life Physical Component Summary | Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years. | Intention to Treat analysis | Posted | Mean | 95% Confidence Interval | units on a scale per year | up to 8 years (annually assessed) |
|
|
|
|
| Secondary | Quality of Life Mental Component Summary | Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years. | Intention to treat analysis | Posted | Mean | 95% Confidence Interval | units on a scale per year | up to 8 years (annually assessed) |
|
|
|
|
| Secondary | Back or Flank Pain | Report of back or flank pain since the last visit (yes or no) | Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures. | Posted | Number | 95% Confidence Interval | percentage of participants at 48 months | 48 months |
|
|
|
|
| 88 |
| 242 |
| 66 |
| 242 |
| EG001 | ACE-I + ARB | ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. | 88 | 244 | 60 | 244 |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Endocrine disorders - Other, specify | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal varices hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sudden death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anaphylaxis | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury to carotid artery | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Bladder anastomotic leak | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Intraoperative renal injury | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ischemia cerebrovascular | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pregnancy, puerperium and perinatal conditions - Other, specify | Pregnancy, puerperium and perinatal conditions | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mania | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal hemorrhage | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Uterine hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic floor muscle weakness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011480 |
| Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |