Not provided
Not provided
Not provided
The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benazepril/amlodipine | Experimental | Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of < 140/< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg. |
|
| Benazepril/hydrochlorothiazide | Active Comparator | Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of < 140/< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1 | Drug | Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event | CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes. | For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event | Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG). | For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria applied to the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| sites in Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19052124 | Result | Jamerson K, Weber MA, Bakris GL, Dahlof B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28. doi: 10.1056/NEJMoa0806182. | |
| 33216879 | Derived |
Not provided
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Benazepril/Amlodipine | Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2 | Drug | Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily. |
|
| Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter | Drug | Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure. |
|
| Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1 | Drug | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily. |
|
| Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2 | Drug | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily. |
|
| Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter | Drug | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure. |
|
| Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes. | For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) |
| Denmark |
| Denmark |
| sites in Finland | Finland | Finland |
| sites in Norway | Norway | Norway |
| sites in Sweden | Sweden | Sweden |
| Brook RD, Kaciroti N, Bakris G, Dahlof B, Pitt B, Velazquez E, Weber MA, Jamerson KA. Cardiovascular Benefits of Angiotensin-Converting Enzyme Inhibition Plus Calcium Channel Blockade in Patients Achieving Tight Blood Pressure Control and With Resistant Hypertension. Am J Hypertens. 2021 May 22;34(5):531-539. doi: 10.1093/ajh/hpaa192. |
| 23219284 | Derived | Weber MA, Jamerson K, Bakris GL, Weir MR, Zappe D, Zhang Y, Dahlof B, Velazquez EJ, Pitt B. Effects of body size and hypertension treatments on cardiovascular event rates: subanalysis of the ACCOMPLISH randomised controlled trial. Lancet. 2013 Feb 16;381(9866):537-45. doi: 10.1016/S0140-6736(12)61343-9. Epub 2012 Dec 6. |
| 20620720 | Derived | Weber MA, Bakris GL, Jamerson K, Weir M, Kjeldsen SE, Devereux RB, Velazquez EJ, Dahlof B, Kelly RY, Hua TA, Hester A, Pitt B; ACCOMPLISH Investigators. Cardiovascular events during differing hypertension therapies in patients with diabetes. J Am Coll Cardiol. 2010 Jun 29;56(1):77-85. doi: 10.1016/j.jacc.2010.02.046. |
| 20170948 | Derived | Bakris GL, Sarafidis PA, Weir MR, Dahlof B, Pitt B, Jamerson K, Velazquez EJ, Staikos-Byrne L, Kelly RY, Shi V, Chiang YT, Weber MA; ACCOMPLISH Trial investigators. Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of a randomised controlled trial. Lancet. 2010 Apr 3;375(9721):1173-81. doi: 10.1016/S0140-6736(09)62100-0. Epub 2010 Feb 18. |
| Benazepril/Hydrochlorothiazide |
Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benazepril/Amlodipine | Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily |
| BG001 | Benazepril/Hydrochlorothiazide | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event | CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes. | Intent-to-treat population: All randomized patients by assigned treatment group | Posted | Number | Percentage of Patients with an event | For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event | Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG). | Intent-to-treat population: All randomized patients by assigned treatment group | Posted | Number | Percentage of Patients with an Event | For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])] |
| |||||||||||||||||||||||||||||||
| Secondary | Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes. | Intent-to-treat population: All randomized patients by assigned treatment group | Posted | Number | Percentage of Patients with an Event | For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) |
|
Double-blind period
Safety population includes all randomized patients who took at least one dose of study medication by actual treatment group (7 Benazepril / Amlodipine and 2 Benazepril / HCTZ patients did not take study medication; 3 patients assigned to Benazepril / HCTZ received Benazepril / Amlodipine medication instead).
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 | Benazepril / Amlodipine | Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily | 1,844 | 5,740 | 3,077 | 5,740 | ||
| EG001 | Benazepril / HCTZ | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily | 2,026 | 5,757 | 2,663 | 5,757 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired haemophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Blood disorder | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypoprothrombinaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| AV dissociation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac hypertrophy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac ventricular disorder | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery restenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Trifascicular block | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Congenital syphilitic osteochondritis | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Adrenal mass | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Antidiuretic hormone abnormality | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hyperparathyroidism primary | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hyphaema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Caecitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diabetic gastropathy | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticulum oesophageal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enterocele | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatic cyst | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal fibrosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tongue oedema | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Decapitation | General disorders | MedDRA | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pelvic mass | General disorders | MedDRA | Systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA | Systematic Assessment |
| |
| Vestibulitis | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Chronic hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic congestion | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Sphincter of Oddi dysfunction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Allergy to vaccine | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Coccidioidomycosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis klebsiella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Groin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected epidermal cyst | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intestinal gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral labyrinthitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Anaesthetic complication neurological | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Device migration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Failure of implant | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Implantable defibrillator malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lung injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pacemaker complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pocket erosion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pubic rami fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Surgical procedure repeated | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Urethral stricture postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Band neutrophil count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Biopsy liver | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure orthostatic decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac stress test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac stress test normal | Investigations | MedDRA | Systematic Assessment |
| |
| Cardioactive drug level increased | Investigations | MedDRA | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Coagulation test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Scan myocardial perfusion abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Podagra | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone erosion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Anal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign colonic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign duodenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bone sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gliosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leiomyosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant lymphoid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant neoplasm of islets of Langerhans | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer stage IIIB | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Oropharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Penile malignant neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Penis carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Refractory anaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Sebaceous adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small cell lung cancer extensive stage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small intestine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Spindle cell sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Vaginal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Alcoholic seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anoxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Critical illness polyneuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Drop attacks | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Global amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Narcolepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve root lesion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Simple partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Supranuclear palsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tarsal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vertebral artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Perineal laceration | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Agitated depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrosclerosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal aneurysm | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery arteriosclerosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Stag horn calculus | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Colpocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatism | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Laryngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cardiac assistance device user | Social circumstances | MedDRA | Systematic Assessment |
| |
| Joint prosthesis user | Social circumstances | MedDRA | Systematic Assessment |
| |
| Penile prosthesis user | Social circumstances | MedDRA | Systematic Assessment |
| |
| Arterial bypass operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic intramural haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic rupture | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial insufficiency | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial restenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arteriosclerosis obliterans | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Femoral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypoperfusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Infarction | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Labile hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Renovascular hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Subclavian steal syndrome | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Takayasu's arteritis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous occlusion | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous stasis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
Study was stopped early, as recommended by the Data Monitoring Committee, due to positive efficacy results.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C044946 | benazepril |
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|