Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In Germany nearly half of the population present elevated values of blood pressure, with - as a result of lifestyle factors and a growing average age - further increasing numbers.
Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events, and renal insufficiency. Thus, hypertension therapy focuses on the reduction of these complications.
The aims of the 3A-registry are the characterization of outpatients with hypertension, their diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance and success, clinical events, and an assessment of overall guideline adherence in the treatment of these patients.
Patients fulfilling the relevant criteria are enrolled and followed up by their general practitioner or medical specialist.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Patients getting Aliskiren at baseline |
| |
| ACE-I/ARB | Patients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren |
| |
| No RAS-inhibition | Patients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100 | baseline and 1 year |
| Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 | Baseline and 1 year |
| Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100 | Baseline and 2 years |
| Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 | Baseline and 2 years |
| Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100 | Baseline and 3 years |
| Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Adherence Regarding Drug Treatment | Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) | Baseline and 1 year |
| Therapy Adherence Regarding Drug Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Consecutive outpatients with arterial hypertension and treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade.
In order to collect enough information on Aliskiren treatment ratio between therapy alternatives should be 4 (Aliskiren) to 1 (ACE inhibitor/ARB) to 1 (no RAS blockade)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Uwe Zeymer, M.D. | Stiftung Institut für Herzinfarktforschung | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25305705 | Derived | Zeymer U, Dechend R, Riemer T, Kaiser E, Senges J, Pittrow D, Schmieder RE; 3A Registry Investigators. 1-Year outcomes of hypertension management in 13,000 outpatients under practice conditions: prospective 3A registry. Int J Cardiol. 2014 Oct 20;176(3):589-94. doi: 10.1016/j.ijcard.2014.07.089. Epub 2014 Aug 1. | |
| 23474245 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren | Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered. |
| FG001 | ACE-I/ARB | Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered. |
| FG002 | No RAS-inhibition | Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Year |
|
| ||||||||||||||||||
| 2nd Year |
| |||||||||||||||||||
| 3rd Year |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Patients treated with Aliskiren (DRI) |
| BG001 | Group B | Patients treated with ACE-I or ARB (ARB/ACE-I) |
| 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 | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100 | Posted | Mean | Standard Deviation | percent change | baseline and 1 year |
|
Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Patients treated with Aliskiren (DRI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Dr. Uwe Zeymer | Foundation Stiftung Institut fuer Herzinfarktforschung Ludwigshafen, Germany | +49 621 503 2813 | Uwe.Zeymer@t-online.de |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C446481 | aliskiren |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ACE-I/ARB | Drug |
|
| No RAS-inhibition | Drug |
|
| Baseline and 3 years |
Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) |
| Baseline and 2 years |
| Therapy Adherence Regarding Drug Treatment | Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) | Baseline and 3 years |
| Adverse Events | Percentage of participants that experienced at least one adverse event during the first year of observation period | 1 year follow up |
| Adverse Events | Percentage of participants that experienced at least one adverse event during the first two years of observation period | 2 years follow up |
| Adverse Events | Percentage of participants that experienced at least one adverse event during the three years of observation period | 3 years follow up |
| Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Baseline and 1 year |
| Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Baseline and 1 year |
| Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Baseline and 2 years |
| Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Baseline and 2 years |
| Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Baseline and 3 years |
| Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Baseline and 3 years |
| Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | 1 year follow up |
| Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | 2 years follow up |
| Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | 3 years follow up |
| Lehmann MV, Zeymer U, Dechend R, Kaiser E, Hagedorn I, Deeg E, Senges J, Schmieder RE. Ambulatory blood pressure monitoring: is it mandatory for blood pressure control in treated hypertensive patients?: prospective observational study. Int J Cardiol. 2013 Oct 3;168(3):2255-63. doi: 10.1016/j.ijcard.2013.01.209. Epub 2013 Mar 7. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG002 |
| Group C |
Patients without any RAS inhibition (No-RAS-I) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients without any RAS inhibition (No-RAS-I)
|
|
| Secondary | Therapy Adherence Regarding Drug Treatment | Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) | Posted | Number | percentage of patients | Baseline and 1 year |
|
|
|
| Secondary | Therapy Adherence Regarding Drug Treatment | Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) | Posted | Number | percentage of patients | Baseline and 2 years |
|
|
|
| Secondary | Therapy Adherence Regarding Drug Treatment | Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) | Posted | Number | percentage of patients | Baseline and 3 years |
|
|
|
| Secondary | Adverse Events | Percentage of participants that experienced at least one adverse event during the first year of observation period | Posted | Number | percentage of patients | 1 year follow up |
|
|
|
| Secondary | Adverse Events | Percentage of participants that experienced at least one adverse event during the first two years of observation period | Posted | Number | percentage of patients | 2 years follow up |
|
|
|
| Secondary | Adverse Events | Percentage of participants that experienced at least one adverse event during the three years of observation period | Posted | Number | percentage of patients | 3 years follow up |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 1 year |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 1 year |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 2 years |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 2 years |
|
|
|
| Primary | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 | Posted | Mean | Standard Deviation | percent change | Baseline and 1 year |
|
|
|
| Primary | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100 | Patients with RR measurement at baseline and 2 years follow-up | Posted | Mean | Standard Deviation | percent change | Baseline and 2 years |
|
|
|
| Primary | Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 | Posted | Mean | Standard Deviation | percent change | Baseline and 2 years |
|
|
|
| Primary | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100 | Patients with DM or HF and RR measurement at baseline and 3 years follow-up | Posted | Mean | Standard Deviation | percent change | Baseline and 3 years |
|
|
|
| Primary | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100 | Posted | Mean | Standard Deviation | percent change | Baseline and 3 years |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 3 years |
|
|
|
| Secondary | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. | Posted | Mean | Standard Deviation | percent change | Baseline and 3 years |
|
|
|
| Secondary | Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | Posted | Number | percentage of patients | 1 year follow up |
|
|
|
| Secondary | Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | Posted | Number | percentage of patients | 2 years follow up |
|
|
|
| Secondary | Influence of Anti-hypertensive Treatment on Renal Function | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline | Posted | Number | percentage of patients | 3 years follow up |
|
|
|
| 649 |
| 10,177 |
| 211 |
| 10,177 |
| EG001 | Group B | Patients treated with ACE-I or ARB (ARB/ACE-I) | 136 | 2,696 | 41 | 2,696 |
| EG002 | Group C | Patients without any RAS inhibition (No-RAS-I) | 84 | 2,113 | 14 | 2,113 |
| Cardiac failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary ostial stenosis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Adams-Stokes syndrome | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic valve sclerosis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bifascicular block | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiomyopathy alcoholic | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chordae tendinae rupture | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary artery insufficiency | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Heart alternation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Myocardial rupture | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sinoatrial block | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sudden cardiac death | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Supraventricular tachyarrhythmia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular dysfunction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular hypertrophy | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrocardiogram QRS complex prolonged | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure diastolic decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Angiogram | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Creatinine urine increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial catheterisation | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood potassium | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Coagulation factor decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Ejection fraction abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrocardiogram QRS complex abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Endoscopy upper gastrointestinal tract | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| General physical condition abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| LDL/HDL ratio increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Pathology test | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| QRS axis | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Antiphospholipid syndrome | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial haemorrhage | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Leriche syndrome | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Macroangiopathy | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vascular compression | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Venous stenosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Withdrawal hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Apallic syndrome | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Brain stem ischaemia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Brain stem stroke | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Coma hepatic | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertonia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| IIIrd nerve paresis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Myelitis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Paresis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac death | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Accidental death | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Concomitant disease progression | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Device failure | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Drug therapeutic incompatibility | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| No adverse event | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ulcer | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pleural disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Stent placement | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Vascular graft | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial stent insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Colectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Dialysis | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Haemodialysis | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Sigmoidectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Adrenalectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Aortic bypass | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Bursa removal | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac pacemaker revision | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac rehabilitation therapy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Carotid artery stent insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Catheter placement | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Central venous catheterisation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Cerebrovascular operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Female genital operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrostomy tube insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Haematoma evacuation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Lymphadenectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Malignant tumour excision | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Mechanical ventilation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Mitral valve repair | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Peripheral artery angioplasty | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Phlebectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Resuscitation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Therapeutic procedure | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Tumour excision | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Encephalitis herpes | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Infectious peritonitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Meningitis herpes | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Pneumocystis jiroveci infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Adrenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Malignant neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to oesophagus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastases to prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Oncologic complication | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Ovarian cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Refractory anaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pancreatic insufficiency | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Shock hypoglycaemic | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Calculus urethral | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Implant site reaction | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Post laminectomy syndrome | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Agoraphobia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Delirium tremens | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Expressive language disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Social phobia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Somatoform disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ocular ischaemic syndrome | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ocular vascular disorder | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Breast calcifications | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostatic atrophy | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Antiphospholipid syndrome | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Preternatural anus | Congenital, familial and genetic disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Joint prosthesis user | Social circumstances | MedDRA (13.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Electrocardiogram QRS complex prolonged | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Not provided
Not provided