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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-101362 | Other Identifier | Japan Pharmaceutical Information Center |
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ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tolvaptan | Experimental | Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolvaptan | Drug | Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Kidney Volume | Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period. Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month12, Month24, and Month36 |
| Renal Function Test (eGFR) | Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month12, Month24, and Month36 |
| Renal Function Test (Cys-C) | Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Month 12, Month 24, and Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29123425 | Derived | Muto S, Okada T, Yasuda M, Tsubouchi H, Nakajima K, Horie S. Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial. Drug Healthc Patient Saf. 2017 Oct 25;9:93-104. doi: 10.2147/DHPS.S142825. eCollection 2017. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan | Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Tohoku Region | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Total Kidney Volume | Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period. Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Posted | Mean | Standard Deviation | mL | Baseline, Month12, Month24, and Month36 |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Renal Function Test (eGFR) | Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Posted | Mean | Standard Deviation | mL/min/1.73 m2 | Baseline, Month12, Month24, and Month36 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Renal Function Test (Cys-C) | Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 12, Month 24, and Month 36 |
|
Through study completion, 2 to 3 years for major patients
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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 | Tolvaptan | Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg | 0 | 135 | 20 | 135 | 134 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Umbilical hernias | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Joint dislocations | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Acute monocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Renal cyst ruptured | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Renal cyst infection | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA/J Ver 17.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 |
| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Units | Counts |
|---|
| Participants |
|
|