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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011360-10 | EudraCT Number |
Not provided
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The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Composite Endpoint | First event among cardiovascular death or non-fatal myocardial infarction | The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | From the date of randomisation to death, up to 48 months | |
| Cardiovascular Mortality | Component of the primary composite endpoint | From the date of randomisation to death, up to 48 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria di Ferrara | Ferrara | 44100 | Italy | |||
| Royal Brompton Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25176136 | Result | Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R; SIGNIFY Investigators. Ivabradine in stable coronary artery disease without clinical heart failure. N Engl J Med. 2014 Sep 18;371(12):1091-9. doi: 10.1056/NEJMoa1406430. Epub 2014 Aug 31. | |
| 24093844 | Result | Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R. Rationale, design, and baseline characteristics of the Study assessInG the morbidity-mortality beNefits of the If inhibitor ivabradine in patients with coronarY artery disease (SIGNIFY trial): a randomized, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease without clinical heart failure. Am Heart J. 2013 Oct;166(4):654-661.e6. doi: 10.1016/j.ahj.2013.06.024. Epub 2013 Sep 17. |
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Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
A total of 23 164 patients were screened, 21 862 were selected and 19 107 were included. The Randomised Set comprised 19 102 patients: 9550 patients in the ivabradine group and 9552 in the placebo group. Of the 19 102 patients in the Randomised Set, 17 724 completed the study: 8830 patients in the ivabradine group and 8894 in the placebo group.
A total of 1181 centres in 51 countries screened at least one patient and 1139 centres included at least one patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivabradine | Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
| FG001 | Placebo | Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ivabradine | Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Primary Composite Endpoint | First event among cardiovascular death or non-fatal myocardial infarction | Posted | Number | participants | The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months. |
|
From randomisation to death, up to 48 months
The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivabradine | Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Innovation Pole | Institut de Recherches Internationales Servier (I.R.I.S.) | +33155724366 | clinicaltrials@servier.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. |
|
| Coronary Mortality | Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death | From the date of randomisation to death, up to 48 months |
| Fatal Myocardial Infarction | Non-composite secondary endpoint | From the date of randomisation to death, up to 48 months |
| Non-fatal Myocardial Infarction | Component of the primary composite endpoint | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Elective Coronary Revascularisation | Non-composite secondary endpoint | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Coronary Revascularisation (Elective or Not) | Non-composite secondary endpoint | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction, coronary revascularisation | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Coronary death, non-fatal myocardial infarction | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| Secondary Composite Endpoint | Non-fatal myocardial infarction, coronary revascularisation, unstable angina | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
| London |
| SW3 6NP |
| United Kingdom |
| Physician Decision |
|
| Withdrawal by Subject |
|
Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | All-cause Mortality | Posted | Number | participants | From the date of randomisation to death, up to 48 months |
|
|
|
|
| Secondary | Cardiovascular Mortality | Component of the primary composite endpoint | Posted | Number | participants | From the date of randomisation to death, up to 48 months |
|
|
|
|
| Secondary | Coronary Mortality | Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death | Posted | Number | participants | From the date of randomisation to death, up to 48 months |
|
|
|
|
| Secondary | Fatal Myocardial Infarction | Non-composite secondary endpoint | Posted | Number | participants | From the date of randomisation to death, up to 48 months |
|
|
|
|
| Secondary | Non-fatal Myocardial Infarction | Component of the primary composite endpoint | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Elective Coronary Revascularisation | Non-composite secondary endpoint | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Coronary Revascularisation (Elective or Not) | Non-composite secondary endpoint | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction, coronary revascularisation | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Coronary death, non-fatal myocardial infarction | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| Secondary | Secondary Composite Endpoint | Non-fatal myocardial infarction, coronary revascularisation, unstable angina | Posted | Number | participants | From the date of randomisation to the date of first occurrence of the event, up to 48 months |
|
|
|
|
| 3,379 |
| 9,539 |
| 6,207 |
| 9,539 |
| EG001 | Placebo | Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. | 3,263 | 9,544 | 5,525 | 9,544 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaemia folate deficiency | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoprothrombinaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Platelet dysfunction | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sideroblastic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Accelerated idioventricular rhythm | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adams-Stokes syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve disease mixed | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve sclerosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arteriospasm coronary | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular dissociation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac aneurysm | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac asthma | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cor pulmonale chronic | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery dissection | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery insufficiency | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dressler's syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis noninfective | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Left atrial dilatation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mitral valve prolapse | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myocardial depression | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myocardial fibrosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nodal arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Postinfarction angina | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhythm idioventricular | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Silent myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinoatrial block | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Supraventricular tachyarrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Torsade de pointes | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Trifascicular block | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adenomatous polyposis coli | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Congenital umbilical hernia | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Factor V Leiden mutation | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Metabolic myopathy | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematotympanum | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neurosensory hypoacusis | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vestibular ataxia | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Basedow's disease | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cushing's syndrome | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Empty sella syndrome | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amaurosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cataract diabetic | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Choroidal effusion | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Choroidal neovascularisation | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dacryoadenitis acquired | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic retinal oedema | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Glaucomatous optic disc atrophy | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Macular fibrosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Normal tension glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ophthalmoplegia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Optic atrophy | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pterygium | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal aneurysm | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal artery thrombosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal vascular thrombosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal vein thrombosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinopathy haemorrhagic | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinopathy hypertensive | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinoschisis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acquired oesophageal web | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anal polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Colonic stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dental alveolar anomaly | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenitis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric mucosa erythema | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric varices | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastroduodenal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastroduodenitis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal angiodysplasia haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal dysplasia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal erosion | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hernial eventration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal angina | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal fistula | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal polyp haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mesenteric haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mesenteric occlusion | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mikulicz's disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral submucosal fibrosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Proctitis ulcerative | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sigmoiditis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Splenic artery aneurysm | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Apparent death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device breakage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device extrusion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device failure | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Foreign body reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pacemaker generated arrhythmia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Puncture site haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Biliary tract disorder | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic hepatitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gallbladder perforation | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic mass | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sphincter of Oddi dysfunction | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amyloidosis | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Acute hepatitis C | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Anal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Appendiceal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arteriosclerotic gangrene | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arteriovenous graft site infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial diarrhoea | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial prostatitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Borrelia infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Candida pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis gangrenous | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cervicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cholangitis suppurative | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Chronic hepatitis C | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis klebsiella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Echinococciasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Emphysematous cholecystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis enterococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterobacter sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gallbladder empyema | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis clostridial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis shigella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Herpes zoster infection neurological | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infective myositis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Injection site abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Joint abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Keratitis herpetic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Laryngitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Laryngitis fungal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Legionella infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Mediastinal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Meningitis tuberculous | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Osteomyelitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Perihepatic abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Perineal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia moraxella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary tuberculoma | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Puncture site abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Puncture site infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pyonephrosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Renal tuberculosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory moniliasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Septic arthritis staphylococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Small intestine gangrene | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sputum purulent | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Toxic shock syndrome | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral pericarditis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Wound infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Wound infection pseudomonas | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Accident at home | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Agitation postoperative | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Aortic injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Asbestosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blindness traumatic | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Bone fissure | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac valve rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery restenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Corrosive gastritis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Crushing injury of trunk | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Joint dislocation postoperative | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Osteoradionecrosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Penetrating abdominal trauma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural hypothyroidism | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post-thoracotomy pain syndrome | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Renal haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Silicosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Arteriogram carotid | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Biopsy prostate | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood parathyroid hormone decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Carbohydrate antigen 19-9 increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac stress test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cardiovascular evaluation | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cystoscopy normal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| ECG signs of myocardial ischaemia | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram ambulatory | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal examination | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Investigation | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary arterial pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Romberg test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Sleep study | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Streptococcus test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Stress echocardiogram abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Thyroid function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Treponema test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insulin-requiring type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Type 3 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| CREST syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Exostosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myopathy toxic | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteochondritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteoporosis postmenopausal | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sympathetic posterior cervical syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adenolymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adenosquamous cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Angiofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Astrocytoma, low grade | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| B precursor type acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Basosquamous carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Benign neoplasm of prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Benign pleural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder cancer stage I, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder transitional cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder transitional cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bladder transitional cell carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Brain stem glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Carcinoid tumour of the stomach | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Carotid body tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral hygroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cervix carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia stage 2 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Clear cell sarcoma of soft tissue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ear neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gallbladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastric cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Haemangioma of bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Large cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Large cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Large cell lung cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Large intestine benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lip and/or oral cavity cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm of choroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant oligodendroglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to abdominal cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to bone marrow | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to the mediastinum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastatic uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Myeloproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neuroendocrine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Nodular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Non-small cell lung cancer stage IIIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ovarian epithelial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Papillary tumour of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Penis carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngeal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pineal parenchymal neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pleural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostate cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Renal cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Rhabdomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Skin cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Spinal meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of pharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of the hypopharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Testicular cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Urethral cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anticholinergic syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Autonomic neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Brain hypoxia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid aneurysm rupture | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery aneurysm | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery disease | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carotid sinus syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebellar atrophy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebellar ischaemia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebellar syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral artery stenosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral microangiopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervical myelopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cranial nerve paralysis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dementia of the Alzheimer's type, with delusions | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drop attacks | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dystonic tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Encephalomyelitis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Essential tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Horner's syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intracranial hypotension | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischaemic neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myelitis transverse | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nerve root lesion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuritis cranial | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neurodegenerative disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Post-injection delirium sedation syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Post-traumatic headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Radial nerve compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Radicular pain | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Radicular syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retrograde amnesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal vascular disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spondylitic myelopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombotic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tonic convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Transient global amnesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ulnar neurapraxia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ulnar tunnel syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| VIth nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vascular dementia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertebral artery occlusion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertebral artery stenosis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertigo CNS origin | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vocal cord paresis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Wernicke-Korsakoff syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Agitated depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Delirium tremens | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Delusional disorder, unspecified type | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysthymic disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hallucinations, mixed | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Impulsive behaviour | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intentional drug misuse | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mood disorder due to a general medical condition | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Obsessive thoughts | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Persecutory delusion | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychosomatic disease | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep terror | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder dilatation | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder diverticulum | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder neck sclerosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder stenosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bladder tamponade | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Calculus urethral | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis glandularis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydroureter | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal artery occlusion | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal artery thrombosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal ischaemia | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urethral disorder | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urethral obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acquired phimosis | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Breast disorder | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Genital prolapse | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Varicocele | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vulval disorder | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cyanosis central | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Granulomatous pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lung cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary microemboli | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Keloid scar | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Necrobiosis lipoidica diabeticorum | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Parapsoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pemphigus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin ulcer haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Activities of daily living impaired | Social circumstances | MedDRA 16.0 | Systematic Assessment |
|
| Alcohol use | Social circumstances | MedDRA 16.0 | Systematic Assessment |
|
| Immobile | Social circumstances | MedDRA 16.0 | Systematic Assessment |
|
| Impaired driving ability | Social circumstances | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Alcohol detoxification | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Aortic bypass | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Arterial bypass operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Arterial stent insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Bladder neoplasm surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Blepharoplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac aneurysm repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac rehabilitation therapy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Carotid angioplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery bypass | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Carotid artery stent insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Chemotherapy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cholesteatoma removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Circumcision | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Coronary revascularisation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus management | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Dupuytren's contracture operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Fasciectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Femoral hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Finger amputation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Gastric banding | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Hydrocele operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Ileostomy closure | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Incisional hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Infusion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Intraocular lens extraction | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Keratoplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Lens extraction | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Liver operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Metatarsal excision | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Mitral valve repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Nasal polypectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Obesity surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Oophorectomy bilateral | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery angioplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery bypass | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery stent insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Physiotherapy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Radical hysterectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Removal of internal fixation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Renal artery ablation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Renal stone removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Retinal laser coagulation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Suture insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Toe amputation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Urethral dilation procedure | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Urinary calculus removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Uterine polypectomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Vaginal prolapse repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic dilatation | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic occlusion | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arterial rupture | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic macroangiopathy | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic microangiopathy | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetic vascular disorder | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Femoral artery dissection | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Femoral artery embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Iliac artery rupture | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Labile blood pressure | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leriche syndrome | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphostasis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery dissection | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Phlebitis superficial | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subclavian artery occlusion | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subclavian steal syndrome | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subgaleal haematoma | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Systolic hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Varicose ulceration | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vasculitis necrotising | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Withdrawal hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review publication and/or communication related to the study results and can require changes. In case of a patent application, the sponsor can delay its authorization for publication or communication of the study results until the date of international registration of the patent.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |