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The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADPKD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolvaptan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Slope of Total Kidney Volume During Pre-administration and Administration | Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope. | Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | Among cases included in the safety analysis, we counted and listed the number of patients whose ALT levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration | e-GFR was used as a biomarker to evaluate ADPKD progression. Values recorded in the CRF were prioritized; if unavailable, e-GFR was calculated using serum creatinine levels with a gender-specific formula. Male: e-GFR=194×(serum creatinine (mg/dL))^-1.094 ×(age)^-0.287 Female: e-GFR=[194×(serum creatinine (mg/dL))^-1.094 ×(age)^-0.287]×0.739 The pre-treatment Estimated Slope was determined for subjects with e-GFR data both before and at the start of tolvaptan administration (baseline). Since the date of initiating tolvaptan administration is considered the start date of the study, the e-GFR measured prior to administration falls outside the study period. The during-treatment Estimated Slope was calculated for subjects with e-GFR measurements at baseline and during treatment, based on the rate of change from baseline to follow-up. |
Inclusion Criteria:
Exclusion Criteria:
-
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medical institutes all over Japan
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| Name | Affiliation | Role |
|---|---|---|
| Yasuhiko Fukuta, PhD | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Co., Ltd. | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39953249 | Derived | Mochizuki T, Muto S, Suzue K, Komaniwa S, Tanaka T, Fukuta Y, Yamashige Y. Safety and efficacy of tolvaptan in real-world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW-PKD surveillance. Clin Exp Nephrol. 2025 Jun;29(6):807-817. doi: 10.1007/s10157-025-02634-7. Epub 2025 Feb 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADPKD | Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADPKD | Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Slope of Total Kidney Volume During Pre-administration and Administration | Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope. | Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline TKV data. During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment TKV data. Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1,672 cases analyzed for efficacy. | Posted | Mean | Standard Deviation | %/year |
Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
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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 | ADPKD | Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA/J version 25. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Investigator in charge | Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd | +81-6-6943-7722 | komaniwa.satoshi@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2021 | Jul 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2023 | Jul 1, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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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| From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). |
| The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | Among cases included in the safety analysis, we counted and listed the number of patients whose AST levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) | From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). |
| Pre-administration: From the first pre-treatment measurement (up to 10 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). |
| The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older | The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 192 elderly patients aged 65 years and older, and compared with those in non-elderly patients under 65 years of age. | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
| Safety in Patients With Advanced ADPKD | Adverse events were summarized in patients with advanced ADPKD who had their creatinine clearance measured at the start of tolvaptan treatment. Patients with advanced ADPKD were defined as those with a pre-treatment creatinine clearance of less than 60 mL/min. The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 752 patients with creatinine clearance <60 mL/min, 261 patients with clearance between 60 and <80 mL/min, and 331 patients with clearance ≥80 mL/min, and the rates were compared across the creatinine clearance groups. | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
| Safety of Long-term Treatment for ADPKD | In the clinical trials conducted prior to approval, there were no cases in which Samsca was administered continuously for more than three years. In this post-marketing surveillance, cases exceeding the three-year (36-month) treatment period of the pre-approval clinical trials were classified as long-term treatment cases. The safety of long-term treatment was evaluated based on the incidence rate of adverse drug reactions (ADRs) according to the timing of their onset. | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Complication | Count of Participants | Participants |
|
| Predisposition to hypersensitivity | Count of Participants | Participants |
|
| History of drug adverse reactions | Count of Participants | Participants |
|
| Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). |
|
|
|
| Secondary | The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | Among cases included in the safety analysis, we counted and listed the number of patients whose ALT levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) | Safety analysis population (n = 1,672) | Posted | Number | participants | From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). |
|
|
|
| Secondary | The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L) | Among cases included in the safety analysis, we counted and listed the number of patients whose AST levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672) | Safety analysis population (n = 1,672) | Posted | Number | participants | From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days). |
|
|
|
| Other Pre-specified | Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration | e-GFR was used as a biomarker to evaluate ADPKD progression. Values recorded in the CRF were prioritized; if unavailable, e-GFR was calculated using serum creatinine levels with a gender-specific formula. Male: e-GFR=194×(serum creatinine (mg/dL))^-1.094 ×(age)^-0.287 Female: e-GFR=[194×(serum creatinine (mg/dL))^-1.094 ×(age)^-0.287]×0.739 The pre-treatment Estimated Slope was determined for subjects with e-GFR data both before and at the start of tolvaptan administration (baseline). Since the date of initiating tolvaptan administration is considered the start date of the study, the e-GFR measured prior to administration falls outside the study period. The during-treatment Estimated Slope was calculated for subjects with e-GFR measurements at baseline and during treatment, based on the rate of change from baseline to follow-up. | Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline e-GFR data. During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment e-GFR data. Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1672 cases analyzed for efficacy. | Posted | Mean | Standard Error | %/year | Pre-administration: From the first pre-treatment measurement (up to 10 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later). |
|
|
|
| Other Pre-specified | The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older | The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 192 elderly patients aged 65 years and older, and compared with those in non-elderly patients under 65 years of age. | Elderly patients: Aged 65 years and older Non-elderly patients: Aged under 65 years | Posted | Count of Participants | Participants | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
|
|
|
| Other Pre-specified | Safety in Patients With Advanced ADPKD | Adverse events were summarized in patients with advanced ADPKD who had their creatinine clearance measured at the start of tolvaptan treatment. Patients with advanced ADPKD were defined as those with a pre-treatment creatinine clearance of less than 60 mL/min. The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 752 patients with creatinine clearance <60 mL/min, 261 patients with clearance between 60 and <80 mL/min, and 331 patients with clearance ≥80 mL/min, and the rates were compared across the creatinine clearance groups. | The study cases were divided into the following three groups based on creatinine clearance before administration, and the incidence rate of ADRs was calculated for each group: less than 60 mL/min, 60 to less than 80 mL/min, and 80 mL/min or more. | Posted | Count of Participants | Participants | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
|
|
|
| Other Pre-specified | Safety of Long-term Treatment for ADPKD | In the clinical trials conducted prior to approval, there were no cases in which Samsca was administered continuously for more than three years. In this post-marketing surveillance, cases exceeding the three-year (36-month) treatment period of the pre-approval clinical trials were classified as long-term treatment cases. The safety of long-term treatment was evaluated based on the incidence rate of adverse drug reactions (ADRs) according to the timing of their onset. | The incidence rate of ADRs was calculated for each time interval from the start of administration. Cases exceeding 36 months were classified as long-term treatment. In cases where the same ADR occurred multiple times in the same patient, all occurrences were included in the calculation. | Posted | Count of Participants | Participants | Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years). |
|
|
|
| 21 |
| 1,672 |
| 253 |
| 1,672 |
| 1,086 |
| 1,672 |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Chronic Heart Failure | Cardiac disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Colonic polyps | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Death | General disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hemorrhagic cyst | General disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Peripheral edema | General disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Drug-induced Liver Injury | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Cysts | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Damage | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Dysfunction | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Infectious Cyst | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Cyst Infection | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Cyst Infection | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Scar hernia | Injury, poisoning and procedural complications | MedDRA/J version 25. | Non-systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increase in Blood Creatinine | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increase in Blood Osmotic Pressure | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increase in C-Reactive Protein | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increase in Liver Enzymes | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J version 25. | Non-systematic Assessment |
|
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J version 25. | Non-systematic Assessment |
|
| Malignant Neoplasm of the Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J version 25. | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J version 25. | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Putaminal hemorrhage | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| End-Stage Renal Disease | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Cyst Hemorrhage | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Dysfunction | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Ureteral Calculi | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Severe menstrual bleeding | Reproductive system and breast disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Aortic Dissection | Vascular disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Cyst Infection | Infections and infestations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Function Disorder | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Liver Disorder | Hepatobiliary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Renal Dysfunction | Renal and urinary disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increased Blood Creatine Phosphokinase | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increased Blood Creatinine | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
| Increased Gamma-Glutamyltransferase | Investigations | MedDRA/J version 25. | Non-systematic Assessment |
|
Not provided
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| D052776 |
| Female Urogenital Diseases |
| 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 |
| Title | Measurements |
|---|---|
|
| 1500 days |
|
| 2000 days |
|
| 2500 days |
|
| 3000 days |
|
| Title | Measurements |
|---|---|
|
| 1500 days |
|
| 2000 days |
|
| 2500 days |
|
| 3000 days |
|
|
|
|
| creatinine clearance ≥80 mL/min |
|
|
|
| 15-21 days |
|
|
| >21 days to ≤3 months |
|
|
| >3 to ≤6 months |
|
|
| >6 to ≤9 months |
|
|
| >9 to ≤12 months |
|
|
| >12 to ≤24 months |
|
|
| >24 to ≤36 months |
|
|
| >36 to ≤48 months |
|
|
| >48 to ≤60 months |
|
|
| >60 to ≤72 months |
|
|
| >72 to ≤84 months |
|
|
| >84 months |
|
|