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The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events | 3 years after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure at 6 Months | initiation and 6 months | |
| Change From Baseline in Diastolic Blood Pressure at 6 Months | initiation and 6 months | |
Not provided
Inclusion criteria:
Hypertension patients unadministered Micardis.
Exclusion criteria:
Not provided
Not provided
Japanese hypertension patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
Not provided
In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan |
| 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 Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events | All of observed 20,443 patients were included as intention to treat set | Posted | Number | Number of participants | 3 years after initiation of treatment |
|
|
From signing the informed consent through the end of study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
Not provided
This study is prospective observational study with no limitation of other antihypertensive treatment in compliance with Japanese Pharmaceutical Affairs Law (JPAL) and Good Post-marketing Study Practice (GPSP).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
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| Change From Baseline in Systolic Blood Pressure at 12 Months |
| initiation and 12 months |
| Change From Baseline in Diastolic Blood Pressure at 12 Months | initiation and 12 months |
| Change From Baseline in Systolic Blood Pressure at 24 Months | initiation and 24 months |
| Change From Baseline in Diastolic Blood Pressure at 24 Months | initiation and 24 months |
| Change From Baseline in Systolic Blood Pressure at 36 Months | initiation and 36 months |
| Change From Baseline in Diastolic Blood Pressure at 36 Months | initiation and 36 months |
| years old |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure at 6 Months | The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 6 months |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure at 6 Months | The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 6 months |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure at 12 Months | The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 12 months |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure at 12 Months | The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 12 months |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure at 24 Months | The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 24 months |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure at 24 Months | The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 24 months |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure at 36 Months | The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 36 months |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure at 36 Months | The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded. | Posted | Mean | Standard Deviation | mmHg | initiation and 36 months |
|
|
|
| 1,058 |
| 20,443 |
| 0 |
| 20,443 |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Blood disorder | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic valve disease mixed | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Cardiac sarcoidosis | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Myocardial rupture | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA13.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA13.1 | Systematic Assessment |
|
| Primary hyperaldosteronism | Endocrine disorders | MedDRA13.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA13.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA13.1 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA13.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA13.1 | Systematic Assessment |
|
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Mesenteric occlusion | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Rectal lesion | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA13.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Arteriosclerotic gangrene | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Gallbladder abscess | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Peritoneal tuberculosis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary tuberculoma | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Pyometra | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA13.1 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Internal injury | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Uterine rupture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Adult T-cell lymphoma/leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Gastric cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Oesophageal carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Pancreatic carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Pharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Pleural mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Retroperitoneal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Thymoma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| IIIrd nerve paralysis | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Quadriplegia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Vertebral artery stenosis | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA13.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Lupus nephritis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Nephrosclerosis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA13.1 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA13.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Caplanas syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic anastomosis | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Dialysis device insertion | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Orthopedic procedure | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Vascular graft | Surgical and medical procedures | MedDRA13.1 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic occlusion | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Aortic rupture | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |