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The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olmesartan medoxomil tablets 10mg to 40 mg |
|
| 2 | Placebo Comparator | Matching placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil | Drug | Tablets 10, 20, or 40 mg |
| |
| Placebo Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Composite Outcomes | first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease | Randomization to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Cardiovascular Composite Outcomes | Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization. | Within 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Manager | R&D Division, Daiichi Sankyo Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38682786 | Derived | Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2. | |
| 24013685 | Derived | Imai E, Haneda M, Chan JC, Yamasaki T, Kobayashi F, Ito S, Makino H. Reduction and residual proteinuria are therapeutic targets in type 2 diabetes with overt nephropathy: a post hoc analysis (ORIENT-proteinuria). Nephrol Dial Transplant. 2013 Oct;28(10):2526-34. doi: 10.1093/ndt/gft249. Epub 2013 Sep 7. |
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During 6-week screening, patients were treated with placebo and assessed for eligibility. Eligible patients were assigned to 10mg of olmesartan or placebo. 857 were screened; 577 were randomized; 566=the full analysis set (11 who completed were excluded for protocol violations). Data are based on the participants in the full analysis set.
The study population was defined by the inclusion criteria. This study was carried out at 74 centers in Japan and 3 centers in Hong Kong. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. First Patient in: 19 May 2003.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olmesartan Medoxomil | Experimental: Olmesartan medoxomil tablets 10mg to 40 mg |
| FG001 | Placebo Comparator | Matching placebo tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olmesartan Medoxomil | Experimental: Olmesartan medoxomil tablets 10mg to 40 mg |
| BG001 | Placebo Comparator | Matching placebo tablets |
| 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 | Renal Composite Outcomes | first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease | Full analysis set=566 | Posted | Number | participants | Randomization to 5 years |
|
|
From baseline to up to 226 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olmesartan Medoxomil | Experimental: Olmesartan medoxomil tablets 10mg to 40 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Kessler | Daiichi Sankyo, Inc | 732-590-5032 | hmkessler@dsi.com |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| Drug |
Matching placebo tablets |
|
| The Change in Proteinuria | The median percentage change from baseline value in urinary protein:creatinine ratio | Randomization to 5 years |
| Reciprocal (1/Serum Creatinine) of Serum Creatinine | The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study. | Randomization to 5 years |
| Tokyo |
| Japan |
| 21993710 | Derived | Imai E, Chan JC, Ito S, Yamasaki T, Kobayashi F, Haneda M, Makino H; ORIENT study investigators. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study. Diabetologia. 2011 Dec;54(12):2978-86. doi: 10.1007/s00125-011-2325-z. Epub 2011 Oct 13. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Use of ACE inhibitors | Number | participants |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| HbA1c | Mean | Standard Deviation | Percentage of HbA1c |
|
| Serum creatinine | Mean | Standard Deviation | mg/dL |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Urinary albumin:creatinine ratio | Median | Inter-Quartile Range | g/g |
|
| Urinary protein: creatinine ratio | Median | Inter-Quartile Range | g/g |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants Experiencing Cardiovascular Composite Outcomes | Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization. | Full analysis set=566 | Posted | Number | participants | Within 5 years |
|
|
|
|
| Secondary | The Change in Proteinuria | The median percentage change from baseline value in urinary protein:creatinine ratio | Full analysis set=566 | Posted | Number | Median percentage change in ratio | Randomization to 5 years |
|
|
|
| Secondary | Reciprocal (1/Serum Creatinine) of Serum Creatinine | The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study. | Full analysis set=566 | Posted | Median | Inter-Quartile Range | dL/mg/year | Randomization to 5 years |
|
|
|
| 147 |
| 287 |
| 264 |
| 287 |
| EG001 | Placebo Comparator | Matching placebo tablets | 171 | 288 | 265 | 288 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neprogenic anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Antrioventricular block complete | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nodal arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| sick sinus syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| tachycardia paroxysmal | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| silent myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| vertigo positional | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| sudden hearing loss | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| angle closure glaucoma | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| aphakia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| boardline glaucoma | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cataract diabetic | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinal oedema | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| macular oedema | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| maculopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| retinal detachment | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| retinal hemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| retinal tear | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| retinopathy proliferative | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| vitreous haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| macular hole | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Adominal distension | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| abdominal pain lower | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| anal fistula | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| appendicitis perforated | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| ascites | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| diarroea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| duodenal polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| duodenal ulcer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| entrocolitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| gastric ulcer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| gastritis erosive | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Salivary gland calculus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hernia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Arthritis viral | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Bartholin's abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infected sebaceous cyst | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Intraocular lens dislocation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Medical device site reaction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Myoglobin blood increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Nuclear magnetic resonance imaging brain abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Serum ferritin decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Creatinine urine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Sleep study | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Urine protein/creatinine ratio decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Urine protein/creatinine ratio increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac function test | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Dexamethasone suppression test positive | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Dexamethasone suppression test | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Renal function test | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary function test abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Endoscopy large bowel | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Investigation | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Nephrological examination | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemia unawareness | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Carcinoid tumour of the gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic autonomic neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mononeuropathy multiplex | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cranial nerve paralysis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysthymic disorder | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Psychosomatic disease | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma late onset | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheterisation cardiac | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Uterine prolapse repair | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Vitrectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Continuous positive airway pressure | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Surgical vascular shunt | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Elective surgery | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Arteriovenous shunt operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Blood pressure management | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infuenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Results of Study shall not be published without prior express written consent and approval of Sponsor. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013777 |
| Tetrazoles |
| 144 -week value |
|