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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142567 | Registry Identifier | JapicCTI | |
| JapicCTI-R160847 | Registry Identifier | JapicCTI |
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The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.
This survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.
For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The dose is increased up to 12 mg, as necessary. For patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral administration of 4-8 mg of candesartan cilexetil | Oral administration of 4-8 milligram (mg) of candesartan cilexetil once daily (increased up to 12 mg, as necessary) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil | Drug | candesartan cilexetil tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | ADR are defined as 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 or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Baseline up to 3 years |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cerebrovascular/Cardiovascular Events | Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
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Inclusion Criteria: Hypertensive patients with at least one of the following risk factors:
Exclusion Criteria: Hypertensive patients who meet all of the following conditions ([1] to [3]):
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Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
Not provided
Participants with a historical diagnosis of hypertension with metabolic syndrome-related risk factors were observed in a single treatment group to receive candesartan cilexetil 4 milligrams (mg).
Participants took part in the study at 1,126 investigative sites in Japan from 7 June 2006 to 30 November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan Cilexetil | Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set included all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan Cilexetil | Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | ADR are defined as 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 or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | Participants | Baseline up to 3 years |
|
Baseline up to 3 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | Candesartan Cilexetil | Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | 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 |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
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| Baseline up to 3 years |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | Baseline up to 3 years |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | Baseline up to 3 years |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | Baseline up to 3 years |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Initial Daily Dose of Blopress | Number | Participants |
|
| Blood Pressure | Mean | Standard Deviation | Millimeter of mercury (mmHg) |
|
| Pulse Rate | Mean | Standard Deviation | Pulse per minute |
|
| Height | Mean | Standard Deviation | Centimeter (cm) |
|
| Weight | Mean | Standard Deviation | Kilogram (Kg) |
|
| Body Mass Index | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Fasting Triglycerides | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) |
|
| High Density Lipoprotein (HDL) Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Fasting Blood Glucose | Mean | Standard Deviation | mg/dL |
|
| Glycated Hemoglobin (HbA1c) | It is reported as per National Glycohemoglobin Standardization Program (NGSP) value. | Mean | Standard Deviation | Hemoglobin Percent |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Serum Creatinine | Mean | Standard Deviation | mg/dL |
|
| Urinary Protein | Protein dipstick grading was used to analyze concentration of urinary protein. | Number | Participants |
|
| Urinary Sugar | Number | Participants |
|
| Microalbumin in Urine | Mean | Standard Deviation | Milligram per day (mg/day) |
|
| Insulin | mcU/mL stands for micro international units per milliliter. | Mean | Standard Deviation | mcU/mL |
|
| Apoprotein A | Mean | Standard Deviation | mg/dL |
|
| Apoprotein B | Mean | Standard Deviation | mg/dL |
|
| Adiponectin | Mean | Standard Deviation | Microgram per milliliter (mcg/mL) |
|
| Leptin | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) |
|
| Smoking Status | Number | Participants |
|
| Alcohol Consumption | Number | Participants |
|
| Predisposition to Hypersensitivity | Number | Participants |
|
| Medical History | Number | Participants |
|
| Breakdown of Medical History | Participants may be represented in more than 1 category. | Number | Participants |
|
| Consumption of Concomitant Antihypertensive Medications | Number | Participants |
|
| Breakdown of Concomitant Antihypertensive Medications | Participants may be represented in more than 1 category. | Number | Participants |
|
| Consumption of Concomitant Antidiabetic Medications | Number | Participants |
|
| Breakdown of Concomitant Antidiabetic Medications | Participants may be represented in more than 1 category. | Number | Participants |
|
| Consumption of Concomitant Antihyperlipidemic Drugs | Number | Participants |
|
| Breakdown of Concomitant Antihyperlipidemic Drugs | Participants may be represented in more than 1 category. | Number | Participants |
|
| Consumption of Other Concomitant Medications | Number | Participants |
|
| Breakdown of Other Concomitant Medication | Participants may be represented in more than 1 category. | Number | Participants |
|
| Pulse Wave Velocity | Pulse wave velocity (PWV) is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel. | Mean | Standard Deviation | Centimeter per second (cm/s) |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | Participants | Baseline up to 3 years |
|
|
|
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events | Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Number of events per 1,000 person-years | Baseline up to 3 years |
|
|
|
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Number of events/1,000 person-years | Baseline up to 3 years |
|
|
|
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Number of events/1,000 person-years | Baseline up to 3 years |
|
|
|
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Number of events/1,000 person-years | Baseline up to 3 years |
|
|
|
| 320 |
| 13,804 |
| 230 |
| 13,804 |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic ischaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Cholangitis suppurative | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral haemorrhage traumatic | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatinine abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Gastric cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Renal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Iliac artery stenosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Cholangitis suppurative | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood pressure abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| Title | Measurements |
|---|---|
|
| Subarachnoid Hemorrhage |
|
| Acute Myocardial Infarction |
|
| Hospitalization for Heart Failure |
|
| Intervention/Hospitalization for Angina Pectoris |
|
| Atrial Fibrillation |
|
| Transition to Dialysis |
|
| Renal Transplant |
|
| Dissecting Aortic Aneurysm |
|
| Diabetic Retinopathy |
|
| New-Onset Diabetes |
|
| Primary MACE |
|
| Primary MACE 2 |
|
| Renal Events |
|
| Title | Measurements |
|---|---|
|
| Subarachnoid Hemorrhage |
|
| Acute Myocardial Infarction |
|
| Hospitalization for Heart Failure |
|
| Intervention/Hospitalization for Angina Pectoris |
|
| Atrial Fibrillation |
|
| Transition to Dialysis |
|
| Renal Transplant |
|
| Dissecting Aortic Aneurysm |
|
| Diabetic Retinopathy |
|
| New-Onset Diabetes |
|
| Primary MACE |
|
| Primary MACE 2 |
|
| Renal Events |
|
| Title | Measurements |
|---|---|
|
| Subarachnoid Hemorrhage |
|
| Acute Myocardial Infarction |
|
| Hospitalization for heart Failure |
|
| Intervention/Hospitalization for Angina Pectoris |
|
| Atrial Fibrillation |
|
| Transition to Dialysis |
|
| Renal Transplant |
|
| Dissecting Aortic Aneurysm |
|
| Diabetic Retinopathy |
|
| New-Onset Diabetes |
|
| Primary MACE |
|
| Primary MACE 2 |
|
| Renal Events |
|
| Title | Measurements |
|---|---|
|
| Subarachnoid Hemorrhage |
|
| Acute Myocardial Infarction |
|
| Hospitalization for Heart Failure |
|
| Intervention/Hospitalization for Angina Pectoris |
|
| Atrial Fibrillation |
|
| Transition to Dialysis |
|
| Renal Transplant |
|
| Dissecting Aortic Aneurysm |
|
| Diabetic Retinopathy |
|
| New-Onset Diabetes |
|
| Primary MACE |
|
| Primary MACE 2 |
|
| Renal Events |
|