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The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.
The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCI-196 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCI-196 | Drug | 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AE) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Serum Phosphorus From Baseline to Week 52 | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor | Information at Mitsubishi Pharma America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26670307 | Derived | Locatelli F, Spasovski G, Dimkovic N, Wanner C. Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia. Blood Purif. 2016;41(4):247-53. doi: 10.1159/000441648. Epub 2015 Dec 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCI-196 | 3, 6, 9, 12, or 15 g/ day as titrated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Orange |
| California |
| United States |
| Tarzana | California | United States |
| Orlando | Florida | United States |
| Pembroke Pines | Florida | United States |
| Atlanta | Georgia | United States |
| Gurnee | Illinois | United States |
| Evansville | Indiana | United States |
| Baton Rouge | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Northport | New York | United States |
| Durham | North Carolina | United States |
| Oklahoma City | Oklahoma | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Burlington | Vermont | United States |
| Chesapeake | Virginia | United States |
| Kamloops | British Columbia | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MCI-196 | 3, 6, 9, 12, or 15 g/ day as titrated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Adverse Events (AE) | Posted | Number | participants | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | The Change in Serum Phosphorus From Baseline to Week 52 | Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.) | Posted | Mean | 95% Confidence Interval | mg/dL | 52 weeks |
|
|
52 weeks
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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 | MCI-196 | 3, 6, 9, 12, or 15 g/ day as titrated | 63 | 116 | 106 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive crisis | Vascular disorders |
| |||
| Arteriosclerosis obliterans | Vascular disorders |
| |||
| Haemorrhage | Vascular disorders |
| |||
| Jugular vein thrombosis | Vascular disorders |
| |||
| Malignant hypertension | Vascular disorders |
| |||
| Superior vena caval occlusion | Vascular disorders |
| |||
| Vena cava thrombosis | Vascular disorders |
| |||
| Accelerated hypertension | Vascular disorders |
| |||
| Peripheral arterial occlusive disease | Vascular disorders |
| |||
| Venous stenosis | Vascular disorders |
| |||
| Peripheral vascular disorder | Vascular disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Steal syndrome | Vascular disorders |
| |||
| Pyrexia | General disorders |
| |||
| Catheter related complication | General disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Pneumatosis intestinalis | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Gastritis | Gastrointestinal disorders |
| |||
| Gastrointestinal haemorrhage | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Pancreatitis | Gastrointestinal disorders |
| |||
| Mallory-Weiss syndrome | Gastrointestinal disorders |
| |||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders |
| |||
| Oesophageal stenosis | Gastrointestinal disorders |
| |||
| Bacteraemia | Infections and infestations |
| |||
| Pharyngeal abscess | Infections and infestations |
| |||
| Diabetic foot infection | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Wound infection staphylococcal | Infections and infestations |
| |||
| Wound infection | Infections and infestations |
| |||
| Escherichia urinary tract infection | Infections and infestations |
| |||
| Gangrene | Infections and infestations |
| |||
| Peritonitis bacterial | Infections and infestations |
| |||
| Bronchitis | Infections and infestations |
| |||
| Cellulitis | Infections and infestations |
| |||
| Bacterial sepsis | Infections and infestations |
| |||
| Arteriovenous graft site infection | Infections and infestations |
| |||
| Helicobacter gastritis | Infections and infestations |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Angina pectoris | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Cardiac discomfort | Cardiac disorders |
| |||
| Acute myocardial infarction | Cardiac disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Myocardial ischaemia | Cardiac disorders |
| |||
| Angina unstable | Cardiac disorders |
| |||
| Cardiomyopathy | Cardiac disorders |
| |||
| Cardiac arrest | Cardiac disorders |
| |||
| Atrial flutter | Cardiac disorders |
| |||
| Supraventricular tachycardia | Cardiac disorders |
| |||
| Fluid overload | Metabolism and nutrition disorders |
| |||
| Diabetic ketoacidosis | Metabolism and nutrition disorders |
| |||
| Hyperglycaemia | Metabolism and nutrition disorders |
| |||
| Hyperkalaemia | Metabolism and nutrition disorders |
| |||
| Calciphylaxis | Metabolism and nutrition disorders |
| |||
| Electrolyte imbalance | Metabolism and nutrition disorders |
| |||
| Hypoglycaemia | Metabolism and nutrition disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders |
| |||
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Skin ulcer | Skin and subcutaneous tissue disorders |
| |||
| Lupus nephritis | Renal and urinary disorders |
| |||
| Azotaemia | Renal and urinary disorders |
| |||
| Renal failure acute | Renal and urinary disorders |
| |||
| Hydronephrosis | Renal and urinary disorders |
| |||
| Renal cyst ruptured | Renal and urinary disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Femur fracture | Injury, poisoning and procedural complications |
| |||
| Tibia fracture | Injury, poisoning and procedural complications |
| |||
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications |
| |||
| Hip fracture | Injury, poisoning and procedural complications |
| |||
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications |
| |||
| Vena cava injury | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications |
| |||
| Procedural pain | Injury, poisoning and procedural complications |
| |||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscular weakness | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Ammonia increased | Investigations |
| |||
| International normalised ratio increased | Investigations |
| |||
| Mental status changes | Psychiatric disorders |
| |||
| Drug abuse | Psychiatric disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Pancytopenia | Blood and lymphatic system disorders |
| |||
| Haemorrhagic anaemia | Blood and lymphatic system disorders |
| |||
| Transient ischaemic attack | Nervous system disorders |
| |||
| Lacunar infarction | Nervous system disorders |
| |||
| Metabolic encephalopathy | Nervous system disorders |
| |||
| Partial seizures | Nervous system disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Carotid artery stenosis | Nervous system disorders |
| |||
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Cholecystitis | Hepatobiliary disorders |
| |||
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Flatulence | Gastrointestinal disorders |
| |||
| Impaired gastric emptying | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Oesophagitis | Gastrointestinal disorders |
| |||
| Reflux gastritis | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Abdominal pain lower | Gastrointestinal disorders |
| |||
| Hypoaesthesia oral | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Haematochezia | Gastrointestinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Faecaloma | Gastrointestinal disorders |
| |||
| Ileus | Gastrointestinal disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Abdominal adhesions | Gastrointestinal disorders |
| |||
| Diverticulum intestinal | Gastrointestinal disorders |
| |||
| Haemorrhoids | Gastrointestinal disorders |
| |||
| Polyp colorectal | Gastrointestinal disorders |
| |||
| Glossodynia | Gastrointestinal disorders |
| |||
| Gastrointestinal haemorrhage | Gastrointestinal disorders |
| |||
| Rectal haemorrhage | Gastrointestinal disorders |
| |||
| Umbilical hernia, obstructive | Gastrointestinal disorders |
| |||
| Colonic polyp | Gastrointestinal disorders |
| |||
| Hiatus hernia | Gastrointestinal disorders |
| |||
| Gastrooesophageal reflux disease | Gastrointestinal disorders |
| |||
| Melaena | Gastrointestinal disorders |
| |||
| Oesophageal stenosis | Gastrointestinal disorders |
| |||
| Contusion | Injury, poisoning and procedural complications |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Haemodialysis-induced symptom | Injury, poisoning and procedural complications |
| |||
| Procedural hypertension | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications |
| |||
| Mouth injury | Injury, poisoning and procedural complications |
| |||
| Procedural dizziness | Injury, poisoning and procedural complications |
| |||
| Skin laceration | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications |
| |||
| Excoriation | Injury, poisoning and procedural complications |
| |||
| Joint sprain | Injury, poisoning and procedural complications |
| |||
| Wound | Injury, poisoning and procedural complications |
| |||
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications |
| |||
| Procedural pain | Injury, poisoning and procedural complications |
| |||
| Vascular graft complication | Injury, poisoning and procedural complications |
| |||
| Venous injury | Injury, poisoning and procedural complications |
| |||
| Foot fracture | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications |
| |||
| Ulna fracture | Injury, poisoning and procedural complications |
| |||
| Limb injury | Injury, poisoning and procedural complications |
| |||
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications |
| |||
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications |
| |||
| Procedural hypotension | Injury, poisoning and procedural complications |
| |||
| Post procedural complication | Injury, poisoning and procedural complications |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Orthopnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| Wheezing | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders |
| |||
| Rhonchi | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| Chylothorax | Respiratory, thoracic and mediastinal disorders |
| |||
| Productive cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
| |||
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural rub | Respiratory, thoracic and mediastinal disorders |
| |||
| Rales | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders |
| |||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypercapnia | Respiratory, thoracic and mediastinal disorders |
| |||
| Lung infiltration | Respiratory, thoracic and mediastinal disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Delirium | Psychiatric disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Stress | Psychiatric disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Drug abuse | Psychiatric disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Herpes zoster | Infections and infestations |
| |||
| Lower respiratory tract infection | Infections and infestations |
| |||
| Clostridial infection | Infections and infestations |
| |||
| Pulmonary tuberculosis | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Cellulitis | Infections and infestations |
| |||
| Gangrene | Infections and infestations |
| |||
| Localised infection | Infections and infestations |
| |||
| Nail infection | Infections and infestations |
| |||
| Osteomyelitis | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Bronchitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Sinusitis | Infections and infestations |
| |||
| Enterococcal infection | Infections and infestations |
| |||
| Postoperative wound infection | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Bacterial disease carrier | Infections and infestations |
| |||
| Subcutaneous abscess | Infections and infestations |
| |||
| Arteriovenous fistula site infection | Infections and infestations |
| |||
| Tooth abscess | Infections and infestations |
| |||
| Clostridium difficile colitis | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Furuncle | Infections and infestations |
| |||
| Peritonitis bacterial | Infections and infestations |
| |||
| Ear infection | Infections and infestations |
| |||
| Hepatitis C | Infections and infestations |
| |||
| Onychomycosis | Infections and infestations |
| |||
| Catheter related infection | Infections and infestations |
| |||
| Catheter site infection | Infections and infestations |
| |||
| Pleural infection bacterial | Infections and infestations |
| |||
| Staphylococcal infection | Infections and infestations |
| |||
| Graft infection | Infections and infestations |
| |||
| Wound infection staphylococcal | Infections and infestations |
| |||
| Oral candidiasis | Infections and infestations |
| |||
| Oesophageal candidiasis | Infections and infestations |
| |||
| Muscle tightness | Musculoskeletal and connective tissue disorders |
| |||
| Osteoporosis | Musculoskeletal and connective tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Neck pain | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Joint swelling | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscle spasms | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Costochondritis | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Osteopenia | Musculoskeletal and connective tissue disorders |
| |||
| Flank pain | Musculoskeletal and connective tissue disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| Bursitis | Musculoskeletal and connective tissue disorders |
| |||
| Trigger finger | Musculoskeletal and connective tissue disorders |
| |||
| Pain in jaw | Musculoskeletal and connective tissue disorders |
| |||
| Groin pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscular weakness | Musculoskeletal and connective tissue disorders |
| |||
| Post herpetic neuralgia | Nervous system disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Hemiparesis | Nervous system disorders |
| |||
| Hypoaesthesia | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Paraesthesia | Nervous system disorders |
| |||
| Facial palsy | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Dementia | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Altered state of consciousness | Nervous system disorders |
| |||
| Presyncope | Nervous system disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Aphasia | Nervous system disorders |
| |||
| Restless legs syndrome | Nervous system disorders |
| |||
| Carotid artery occlusion | Nervous system disorders |
| |||
| Carotid artery stenosis | Nervous system disorders |
| |||
| Pyrexia | General disorders |
| |||
| Chest discomfort | General disorders |
| |||
| Asthenia | General disorders |
| |||
| Malaise | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Feeling hot | General disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Feeling cold | General disorders |
| |||
| Face oedema | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Local swelling | General disorders |
| |||
| Localised oedema | General disorders |
| |||
| Chills | General disorders |
| |||
| Pain | General disorders |
| |||
| Influenza like illness | General disorders |
| |||
| Gait disturbance | General disorders |
| |||
| Catheter related complication | General disorders |
| |||
| Vessel puncture site haemorrhage | General disorders |
| |||
| Inflammation | General disorders |
| |||
| Catheter site pain | General disorders |
| |||
| Breath sounds abnormal | Investigations |
| |||
| Blood cholesterol increased | Investigations |
| |||
| Blood parathyroid hormone increased | Investigations |
| |||
| Methicillin-resistant staphylococcal aureus test positive | Investigations |
| |||
| Electrocardiogram QT prolonged | Investigations |
| |||
| Blood glucose increased | Investigations |
| |||
| Hepatic enzyme increased | Investigations |
| |||
| Blood phosphorus increased | Investigations |
| |||
| Venous pressure increased | Investigations |
| |||
| Ammonia increased | Investigations |
| |||
| Gram stain positive | Investigations |
| |||
| Weight decreased | Investigations |
| |||
| Vitamin D decreased | Investigations |
| |||
| Liver function test abnormal | Investigations |
| |||
| Cardiac murmur | Investigations |
| |||
| Blood creatine phosphokinase increased | Investigations |
| |||
| Chest X-ray abnormal | Investigations |
| |||
| Cardiovascular function test abnormal | Investigations |
| |||
| Activated partial thromboplastin time abnormal | Investigations |
| |||
| International normalised ratio abnormal | Investigations |
| |||
| Prothrombin time abnormal | Investigations |
| |||
| Electrocardiogram T wave abnormal | Investigations |
| |||
| Gamma-glutamyltransferase increased | Investigations |
| |||
| Prostatic specific antigen increased | Investigations |
| |||
| Blood glucose decreased | Investigations |
| |||
| Blood culture positive | Investigations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Hypoglycaemia | Metabolism and nutrition disorders |
| |||
| Hyperkalaemia | Metabolism and nutrition disorders |
| |||
| Hypocalcaemia | Metabolism and nutrition disorders |
| |||
| Hypokalaemia | Metabolism and nutrition disorders |
| |||
| Hyperhomocysteinaemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesaemia | Metabolism and nutrition disorders |
| |||
| Metabolic acidosis | Metabolism and nutrition disorders |
| |||
| Diabetes mellitus | Metabolism and nutrition disorders |
| |||
| Hypercalcaemia | Metabolism and nutrition disorders |
| |||
| Iron deficiency | Metabolism and nutrition disorders |
| |||
| Folate deficiency | Metabolism and nutrition disorders |
| |||
| Vitamin D deficiency | Metabolism and nutrition disorders |
| |||
| Hypernatraemia | Metabolism and nutrition disorders |
| |||
| Hypoalbuminaemia | Metabolism and nutrition disorders |
| |||
| Hypophosphataemia | Metabolism and nutrition disorders |
| |||
| Hypervolaemia | Metabolism and nutrition disorders |
| |||
| Increased appetite | Metabolism and nutrition disorders |
| |||
| Dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Eczema | Skin and subcutaneous tissue disorders |
| |||
| Skin ulcer | Skin and subcutaneous tissue disorders |
| |||
| Rash generalised | Skin and subcutaneous tissue disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Blister | Skin and subcutaneous tissue disorders |
| |||
| Ecchymosis | Skin and subcutaneous tissue disorders |
| |||
| Hyperkeratosis | Skin and subcutaneous tissue disorders |
| |||
| Periorbital oedema | Skin and subcutaneous tissue disorders |
| |||
| Post inflammatory pigmentation change | Skin and subcutaneous tissue disorders |
| |||
| Pruritus generalised | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Rash pruritic | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Acne | Skin and subcutaneous tissue disorders |
| |||
| Skin lesion | Skin and subcutaneous tissue disorders |
| |||
| Urinary tract disorder | Renal and urinary disorders |
| |||
| Azotaemia | Renal and urinary disorders |
| |||
| Haematuria | Renal and urinary disorders |
| |||
| Polyuria | Renal and urinary disorders |
| |||
| Renal failure chronic | Renal and urinary disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Bradycardia | Cardiac disorders |
| |||
| Angina pectoris | Cardiac disorders |
| |||
| Diastolic dysfunction | Cardiac disorders |
| |||
| Coronary artery occlusion | Cardiac disorders |
| |||
| Tachycardia | Cardiac disorders |
| |||
| Atrioventricular block first degree | Cardiac disorders |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Conduction disorder | Cardiac disorders |
| |||
| Bundle branch block left | Cardiac disorders |
| |||
| Cardiac tamponade | Cardiac disorders |
| |||
| Cardiomyopathy | Cardiac disorders |
| |||
| Atrial flutter | Cardiac disorders |
| |||
| Cardiomegaly | Cardiac disorders |
| |||
| Supraventricular tachycardia | Cardiac disorders |
| |||
| Mitral valve incompetence | Cardiac disorders |
| |||
| Tachyarrhythmia | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Orthostatic hypotension | Vascular disorders |
| |||
| Arteriosclerosis obliterans | Vascular disorders |
| |||
| Air embolism | Vascular disorders |
| |||
| Haematoma | Vascular disorders |
| |||
| Jugular vein distension | Vascular disorders |
| |||
| Vasodilatation | Vascular disorders |
| |||
| Venous occlusion | Vascular disorders |
| |||
| Peripheral arterial occlusive disease | Vascular disorders |
| |||
| Arterial thrombosis limb | Vascular disorders |
| |||
| Aortic dilatation | Vascular disorders |
| |||
| Scleral haemorrhage | Eye disorders |
| |||
| Eye swelling | Eye disorders |
| |||
| Ocular hyperaemia | Eye disorders |
| |||
| Conjunctivitis allergic | Eye disorders |
| |||
| Conjunctivitis | Eye disorders |
| |||
| Cataract | Eye disorders |
| |||
| Eye irritation | Eye disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Leukocytosis | Blood and lymphatic system disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Atrial septal defect | Congenital, familial and genetic disorders |
| |||
| Hypothyroidism | Endocrine disorders |
| |||
| Hyperparathyroidism secondary | Endocrine disorders |
| |||
| Gallbladder polyp | Hepatobiliary disorders |
| |||
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Seasonal allergy | Immune system disorders |
| |||
| Inner ear inflammation | Ear and labyrinth disorders |
| |||
| Sudden hearing loss | Ear and labyrinth disorders |
| |||
| Erectile dysfunction | Reproductive system and breast disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C106574 | cholebine |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Denominators | Categories |
|---|
|