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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132328 | Registry Identifier | JapicCTI |
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The purpose of this survey is to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on long-term pioglitazone (Actos Tablets) treatment.
This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20000.
The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone 15 to 30 mg | administered orally once daily before or after breakfast for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events | Cerebral and cardiovascular events (Macroangiopathy) include the following: Sudden death, Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, Acute myocardial infarction, Angina pectoris requiring intervention or hospitalization for treatment, Cardiac failure requiring hospitalization for treatment, Atrial fibrillation, Aortic dissection. Reported data was frequency of participants who met at least one new cerebral and cardiovascular event throughout this study. | From Baseline, Up to 3 Years |
| Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in body weight as a one of metabolic syndrome parameters and for each gender (male/female). | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in waist circumference as a one of metabolic syndrome parameters and for each gender (male/female). | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HbA1c (NGSP) as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point | Changes from baseline in HbA1c (NGSP) with number of MetS-related factor were reported instead. Risk factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, and Family History of Diabetes in Second-Degree Relatives. |
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Inclusion Criteria:
Waist circumference, height, body weight, blood pressure, Haemoglobin A1c (HbA1c), fasting triglyceride, High-density Lipoprotein (HDL)-cholesterol
Exclusion Criteria:
Patients meeting any of the following criteria (1) to (5) will be excluded:
Patients with any contraindications to pioglitazone (Actos Tablets) treatment as specified below:
Cardiac failure, history of cardiac failure, severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, serious hepatic dysfunction, serious renal dysfunction, severe infection, perioperative state, serious trauma, history of hypersensitivity to any ingredients of pioglitazone (Actos Tablets), pregnancy or possible pregnancy
Patients aged < 20 or ≥ 75 years
Patients who currently have or have had any of the following: myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease (including left ventricular hypertrophy with cardiac hypofunction*), atrial fibrillation, atrial flutter, valvular disease, aortic dissection, cerebral infarction, cerebral hemorrhage (including subarachnoid hemorrhage). (*Reduced cardiac function is roughly defined as having a brain natriuretic peptide [BNP] ≥ 40 pg/mL.)
Patients who have taken pioglitazone (Actos Tablets) within 3 months before enrollment in this survey
Patients who have been enrolled in the candesartan cilexetil (Blopress) special drug use surveillance "hypertension: survey on metabolic equivalents (MetS) (Challenge-MetS)" at each medical institution.
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Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg tablet, orally, once daily for up to 3 years.
Participants took part in the study at 1203 investigative sites in Japan, from 16 October 2007 to 30 June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3Month) available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| 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 | Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events | Cerebral and cardiovascular events (Macroangiopathy) include the following: Sudden death, Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, Acute myocardial infarction, Angina pectoris requiring intervention or hospitalization for treatment, Cardiac failure requiring hospitalization for treatment, Atrial fibrillation, Aortic dissection. Reported data was frequency of participants who met at least one new cerebral and cardiovascular event throughout this study. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. | Posted | Number | Percentage of Participants | From Baseline, Up to 3 Years |
|
Up to 3 Years
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
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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 | Pioglitazone | Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 3 years before or after breakfast in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point |
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood glucose as a one of metabolic syndrome parameters. |
| From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood insulin level as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in total cholesterol level as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HDL cholesterol level as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting triglyceride level as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in systolic blood pressure as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in diastolic blood pressure as a one of metabolic syndrome parameters. | From Baseline and final assessment point (Up to 3 Years) |
| From Baseline and final assessment point (Up to 3 Years) |
| Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events | 3 Years |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration of Type 2 Diabetes Mellitus | Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported. | Count of Participants | Participants |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2](streamdown:incomplete-link) | Mean | Standard Deviation | Kilogram (kg)/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | Centimeter (cm) |
|
| Fasting Blood Glucose | Mean | Standard Deviation | Milligram (mg)/dL |
|
| Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | Mean | Standard Deviation | Percent |
|
| Clinical Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
|
| Clinical Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Fasting Triglyceride | Mean | Standard Deviation | mg/dL |
|
| Number of Participants Who Was Current Smoker | Count of Participants | Participants |
|
| Number of Participants Who Was Current Drinker | Count of Participants | Participants |
|
| Number of Participants Who Had Medical History or Medical Complications | Medical history defined as a disease or a health condition for each participant before start of the study. Complications defined as a disease or a health condition for each participant at the start of study. Medical history/Complications was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history/complications included all medical history/complications except for those mentioned above. | Count of Participants | Participants |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in body weight as a one of metabolic syndrome parameters and for each gender (male/female). | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. | Posted | Mean | Standard Deviation | kg | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in waist circumference as a one of metabolic syndrome parameters and for each gender (male/female). | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. | Posted | Mean | Standard Deviation | cm | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HbA1c (NGSP) as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood glucose as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood insulin level as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micro unit/mL | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in total cholesterol level as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HDL cholesterol level as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting triglyceride level as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in systolic blood pressure as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Primary | Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point | Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in diastolic blood pressure as a one of metabolic syndrome parameters. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Secondary | Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point | Changes from baseline in HbA1c (NGSP) with number of MetS-related factor were reported instead. Risk factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, and Family History of Diabetes in Second-Degree Relatives. | Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. | Posted | Mean | Standard Deviation | Percent | From Baseline and final assessment point (Up to 3 Years) |
|
|
|
| Secondary | Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events | Outcome measure, "Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events", on protocol section could not be summarized because study protocol was not defined what is the specific data for association precisely and there were no data to report. | Posted | 3 Years |
|
|
| 82 |
| 17,651 |
| 467 |
| 17,651 |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinocerebellar disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.1 | Systematic Assessment | Additional Description: The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Brain natriuretic peptide abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Peripheral revascularisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
|
|
| Three Factor |
|
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| Four Factor |
|
|